Gelaspan vs Crystalloid Therapy in Sepsis

NCT07172451 | Recruiting Phase 4 DMC

• 2 other identifiers: ZSANES.B2025-465REthics Approval No. B2025-465R
• Study Type: interventional
• Target: 318
• Locations: 1 country
• Sites: 9

Brief Summary

The goal of this randomized clinical trial is to evaluate whether balanced gelatin solution is more effective and safe than balanced crystalloid solution for perioperative fluid management in adults with sepsis undergoing emergency abdominal surgery. Sepsis often causes severe fluid loss from the bloodstream into tissues, leading to low blood pressure, impaired organ function, and the need for urgent fluid resuscitation. Balanced gelatin, a colloid solution, may help maintain intravascular volume more effectively than crystalloid alone. In this study, participants are randomly assigned in a 1:1 ratio to receive either balanced gelatin or Ringer's acetate during surgery and in the first 24 hours afterward. All patients receive standardized anesthesia care, goal-directed fluid therapy, and protocolized use of vasoactive drugs. The main questions the study aims to answer are:

• Does balanced gelatin reduce positive fluid balance within 24 hours after surgery?
• Does it improve hemodynamic stability during the early postoperative period?
• What effects does balanced gelatin have on kidney function, microcirculation, postoperative recovery, and other clinical outcomes? Participants will be followed throughout hospitalization and contacted again on postoperative day 28 and day 90 to assess survival, complications, and health-related quality of life. The trial is double-blind, meaning that patients, clinicians, and outcome assessors do not know which fluid is being used. An independent Data and Safety Monitoring Board will oversee patient safety during the study. The findings of this trial are expected to provide important evidence to guide perioperative fluid resuscitation strategies for septic patients undergoing emergency surgery.

Conditions

Intra-Abdominal Infections; Sepsis

Keywords

Balanced gelatin solution; Succinylated gelatin; Crystalloid; Ringer's acetate; Fluid resuscitation; Goal-directed fluid therapy; Emergency abdominal surgery; Microcirculation; Hemodynamic stabilization; SOFA score; Lactate clearance; Randomized controlled trial

Outcome Measures

Primary Outcomes (2)

• Primary Outcome 1: Net fluid balance within 24 hours after surgery

  \[Hierarchical Testing Sequence: 1st\] This is the first primary endpoint in the hierarchical testing sequence. Net fluid balance is defined as the difference between total infused volume and total output volume during surgery and the first 24 postoperative hours. Input volume includes all study fluids (balanced gelatin solution or acetate Ringer's), albumin, blood products, and maintenance crystalloid infusion. Excluded are solvent volumes \<50 mL and non-therapeutic fluids such as irrigation or enteral/oral intake. Albumin is recorded in mL of solution administered. Blood product volumes are standardized: packed red blood cells 1 unit = 200 mL; plasma = actual volume; apheresis platelets 1 therapeutic dose = 250 mL; cryoprecipitate 1 unit = 25 mL (with center-specific adjustment allowed). Output volume includes intraoperative blood loss, urine output, and measurable drainage (thoracic, abdominal, nasogastric, etc.), excluding insensible or unmeasurable losses.

  Intraoperative period and postoperative 24 hours

• Primary Outcome 2: Proportion of patients achieving hemodynamic stability within 24 hours after surgery

  \[Hierarchical Testing Sequence: 2nd\] This is the second primary endpoint in the hierarchical testing sequence. Hemodynamic stability (HDS) is defined as meeting all of the following three criteria at postoperative 24 hours: 1. Mean arterial pressure (MAP) ≥65 mmHg without vasopressor support, sustained ≥1 hour after discontinuation of vasopressors, with all subsequent MAP measurements ≥65 mmHg. 2. Blood lactate ≤2 mmol/L, based on the most recent venous or arterial sample. 3. Urine output ≥1 mL/kg/h, based on the average over the preceding 6 hours. The outcome measure is the percentage of patients in each group who fulfill all three criteria.

  Postoperative 24 hours

Secondary Outcomes (20)

• Secondary Outcome 1.1: Intensity of study drug use within 24 hours after surgery

  Randomization to postoperative 24 hours

• Secondary Outcome 1.2: Blood product utilization rate within 24 hours after surgery

  Randomization to postoperative 24 hours

• Secondary Outcome 1.3: Vasopressor load within 24 hours after surgery

  Randomization to postoperative 24 hours

• Secondary Outcome 1.4: Proportion of patients receiving inotropic drugs within 24 hours after surgery

  Randomization to postoperative 24 hours

• Secondary Outcome 2.1: Intraoperative lactate reduction magnitude

  Baseline to end of surgery

Other Outcomes (18)

• Safety Outcome 1.1: Incidence of postoperative respiratory complications (ARDS)

  Postoperative day 1 to day 7

• Safety Outcome 1.2: Incidence of postoperative cardiovascular complications (arrhythmias)

  Postoperative day 1 to day 28

• Safety Outcome 1.3: Incidence of postoperative renal complications

  Postoperative day 1 to day 28

Study Arms (2)

Balanced Gelatin Solution

EXPERIMENTAL

Patients randomized to the balanced gelatin group receive balanced gelatin solution (4% succinylated gelatin in a balanced crystalloid carrier) for volume expansion during the surgical procedure, guided by a stroke volume (SV) monitoring protocol. The study fluid management may continue for up to 24 hours post-randomization according to clinical needs. The cumulative dose of balanced gelatin is capped at 30 mL/kg (ideal body weight) within the first 24 hours; once reached or when the study fluid is unavailable, Ringer's acetate is used for subsequent resuscitation.

Drug: Balanced Gelatin Solution

Crystalloid Solution

ACTIVE COMPARATOR

Patients randomized to the crystalloid group receive acetate Ringer's solution as the sole resuscitation fluid during emergency abdominal surgery for sepsis, according to the same goal-directed protocol guided by stroke volume monitoring. No gelatin solution or lactate-containing crystalloids will be administered within the first 24 hours post-randomization. The total volume of crystalloid infusion is not limited.

Drug: Acetate Ringer's Solution

Interventions

Balanced Gelatin Solution DRUG

Description: Balanced gelatin solution (4% succinylated gelatin in a balanced crystalloid carrier). Administered as the primary resuscitation fluid during the intraoperative period and may be continued into the first 24 postoperative hours if clinically indicated and available. Infusion follows a stroke volume-guided, goal-directed fluid therapy protocol. The total dose of the study fluid is capped at 30 mL/kg (ideal body weight) within 24 hours. If the maximum dose is reached or the study fluid is no longer available postoperatively, additional resuscitation is provided with Ringer's acetate solution.

Also known as: Succinylated Gelatin 4%, Gelatin Infusion, Gelaspan

Balanced Gelatin Solution

Acetate Ringer's Solution DRUG

Description: Acetate Ringer's solution, a balanced crystalloid, administered as the sole resuscitation fluid in patients with sepsis undergoing emergency abdominal surgery. Fluid therapy follows the same stroke volume-guided, goal-directed protocol as the experimental arm. This regimen is maintained throughout the intraoperative period and the first 24 postoperative hours to ensure the exclusion of any exogenous colloids or lactate-containing solutions. There is no upper limit for the total volume of crystalloid infusion.

Also known as: Balanced Crystalloid Solution, Ringer's Acetate

Crystalloid Solution

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years.
• Diagnosis of sepsis according to the Sepsis-3 definition, caused by intra-abdominal infection, and requiring emergency abdominal surgery for source control.
• Sequential Organ Failure Assessment (SOFA-2) score ≥ 2 (determined by the most recent available clinical data) and blood lactate \> 2 mmol/L (measured within 6 hours prior to enrollment).
• Subject or legal representative can understand the study purpose and provide written informed consent.

You may not qualify if:

• Received any dose of artificial colloids within 24 hours prior to randomization.
• Predicted mortality within 48 hours (ASA physical status class ≥ V).
• Atrial fibrillation or congestive heart failure.
• Severe Acute Respiratory Distress Syndrome (ARDS).
• Preoperative coagulation dysfunction or receiving anticoagulant therapy.
• Preoperative requirement for renal replacement therapy (long-term or intermittent, including hemodialysis or peritoneal dialysis).
• Acute burns exceeding 10% of the total body surface area.
• Severe hepatic impairment.
• Severe electrolyte disturbance.
• Pregnancy or breastfeeding.
• Known allergy to gelatin.
• Current participation in other interventional clinical trials.

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead
• B. Braun Medical International Trading Company Ltd.: collaborator

Study Sites (9)

The First Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510080, China

NOT YET RECRUITING

Zhongda Hospital, Southeast University

Nanjing, Jiangsu, 210009, China

NOT YET RECRUITING

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215006, China

NOT YET RECRUITING

Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, 221000, China

NOT YET RECRUITING

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

West China Hospital of Sichuan University

Chengdu, Sichuan, 610041, China

NOT YET RECRUITING

Tianjin Medical University General Hospital

Tianjing, Tianjing, 300052, China

NOT YET RECRUITING

The Second Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310058, China

NOT YET RECRUITING

The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University (WMU)

Wenzhou, Zhejiang, 325000, China

NOT YET RECRUITING

Related Publications (30)

• Knaus WA, Draper EA, Wagner DP, Zimmerman JE. APACHE II: a severity of disease classification system. Crit Care Med. 1985 Oct;13(10):818-29.

  PMID: 3928249 BACKGROUND

• Hedrick TL, McEvoy MD, Mythen MMG, Bergamaschi R, Gupta R, Holubar SD, Senagore AJ, Gan TJ, Shaw AD, Thacker JKM, Miller TE, Wischmeyer PE, Carli F, Evans DC, Guilbert S, Kozar R, Pryor A, Thiele RH, Everett S, Grocott M, Abola RE, Bennett-Guerrero E, Kent ML, Feldman LS, Fiore JF Jr; Perioperative Quality Initiative (POQI) 2 Workgroup. American Society for Enhanced Recovery and Perioperative Quality Initiative Joint Consensus Statement on Postoperative Gastrointestinal Dysfunction Within an Enhanced Recovery Pathway for Elective Colorectal Surgery. Anesth Analg. 2018 Jun;126(6):1896-1907. doi: 10.1213/ANE.0000000000002742.

  PMID: 29293183 BACKGROUND

• Lee DH, Dane MJ, van den Berg BM, Boels MG, van Teeffelen JW, de Mutsert R, den Heijer M, Rosendaal FR, van der Vlag J, van Zonneveld AJ, Vink H, Rabelink TJ; NEO study group. Deeper penetration of erythrocytes into the endothelial glycocalyx is associated with impaired microvascular perfusion. PLoS One. 2014 May 9;9(5):e96477. doi: 10.1371/journal.pone.0096477. eCollection 2014.

  PMID: 24816787 BACKGROUND

• Herdman M, Gudex C, Lloyd A, Janssen M, Kind P, Parkin D, Bonsel G, Badia X. Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L). Qual Life Res. 2011 Dec;20(10):1727-36. doi: 10.1007/s11136-011-9903-x. Epub 2011 Apr 9.

  PMID: 21479777 BACKGROUND

• Khwaja A. KDIGO clinical practice guidelines for acute kidney injury. Nephron Clin Pract. 2012;120(4):c179-84. doi: 10.1159/000339789. Epub 2012 Aug 7. No abstract available.

  PMID: 22890468 BACKGROUND

• Vincent JL, Moreno R, Takala J, Willatts S, De Mendonca A, Bruining H, Reinhart CK, Suter PM, Thijs LG. The SOFA (Sepsis-related Organ Failure Assessment) score to describe organ dysfunction/failure. On behalf of the Working Group on Sepsis-Related Problems of the European Society of Intensive Care Medicine. Intensive Care Med. 1996 Jul;22(7):707-10. doi: 10.1007/BF01709751. No abstract available.

  PMID: 8844239 BACKGROUND

• Chappell D, Jacob M, Hofmann-Kiefer K, Conzen P, Rehm M. A rational approach to perioperative fluid management. Anesthesiology. 2008 Oct;109(4):723-40. doi: 10.1097/ALN.0b013e3181863117.

  PMID: 18813052 BACKGROUND

• Qureshi SH, Rizvi SI, Patel NN, Murphy GJ. Meta-analysis of colloids versus crystalloids in critically ill, trauma and surgical patients. Br J Surg. 2016 Jan;103(1):14-26. doi: 10.1002/bjs.9943. Epub 2015 Nov 2.

  PMID: 26522616 BACKGROUND

• van der Heijden M, Verheij J, van Nieuw Amerongen GP, Groeneveld AB. Crystalloid or colloid fluid loading and pulmonary permeability, edema, and injury in septic and nonseptic critically ill patients with hypovolemia. Crit Care Med. 2009 Apr;37(4):1275-81. doi: 10.1097/CCM.0b013e31819cedfd.

  PMID: 19242338 BACKGROUND

• Stockwell MA, Scott A, Day A, Riley B, Soni N. Colloid solutions in the critically ill. A randomised comparison of albumin and polygeline 2. Serum albumin concentration and incidences of pulmonary oedema and acute renal failure. Anaesthesia. 1992 Jan;47(1):7-9. doi: 10.1111/j.1365-2044.1992.tb01942.x.

  PMID: 1536412 BACKGROUND

• Gondos T, Marjanek Z, Ulakcsai Z, Szabo Z, Bogar L, Karolyi M, Gartner B, Kiss K, Havas A, Futo J. Short-term effectiveness of different volume replacement therapies in postoperative hypovolaemic patients. Eur J Anaesthesiol. 2010 Sep;27(9):794-800. doi: 10.1097/EJA.0b013e32833b3504.

  PMID: 20520555 BACKGROUND

• Tseng CH, Chen TT, Wu MY, Chan MC, Shih MC, Tu YK. Resuscitation fluid types in sepsis, surgical, and trauma patients: a systematic review and sequential network meta-analyses. Crit Care. 2020 Dec 14;24(1):693. doi: 10.1186/s13054-020-03419-y.

  PMID: 33317590 BACKGROUND

• Marx G, Schindler AW, Mosch C, Albers J, Bauer M, Gnass I, Hobohm C, Janssens U, Kluge S, Kranke P, Maurer T, Merz W, Neugebauer E, Quintel M, Senninger N, Trampisch HJ, Waydhas C, Wildenauer R, Zacharowski K, Eikermann M. Intravascular volume therapy in adults: Guidelines from the Association of the Scientific Medical Societies in Germany. Eur J Anaesthesiol. 2016 Jul;33(7):488-521. doi: 10.1097/EJA.0000000000000447. No abstract available.

  PMID: 27043493 BACKGROUND

• Brunkhorst FM, Engel C, Bloos F, Meier-Hellmann A, Ragaller M, Weiler N, Moerer O, Gruendling M, Oppert M, Grond S, Olthoff D, Jaschinski U, John S, Rossaint R, Welte T, Schaefer M, Kern P, Kuhnt E, Kiehntopf M, Hartog C, Natanson C, Loeffler M, Reinhart K; German Competence Network Sepsis (SepNet). Intensive insulin therapy and pentastarch resuscitation in severe sepsis. N Engl J Med. 2008 Jan 10;358(2):125-39. doi: 10.1056/NEJMoa070716.

  PMID: 18184958 BACKGROUND

• Perner A, Haase N, Guttormsen AB, Tenhunen J, Klemenzson G, Aneman A, Madsen KR, Moller MH, Elkjaer JM, Poulsen LM, Bendtsen A, Winding R, Steensen M, Berezowicz P, Soe-Jensen P, Bestle M, Strand K, Wiis J, White JO, Thornberg KJ, Quist L, Nielsen J, Andersen LH, Holst LB, Thormar K, Kjaeldgaard AL, Fabritius ML, Mondrup F, Pott FC, Moller TP, Winkel P, Wetterslev J; 6S Trial Group; Scandinavian Critical Care Trials Group. Hydroxyethyl starch 130/0.42 versus Ringer's acetate in severe sepsis. N Engl J Med. 2012 Jul 12;367(2):124-34. doi: 10.1056/NEJMoa1204242. Epub 2012 Jun 27.

  PMID: 22738085 BACKGROUND

• Guidet B, Martinet O, Boulain T, Philippart F, Poussel JF, Maizel J, Forceville X, Feissel M, Hasselmann M, Heininger A, Van Aken H. Assessment of hemodynamic efficacy and safety of 6% hydroxyethylstarch 130/0.4 vs. 0.9% NaCl fluid replacement in patients with severe sepsis: the CRYSTMAS study. Crit Care. 2012 May 24;16(3):R94. doi: 10.1186/cc11358.

  PMID: 22624531 BACKGROUND

• De Backer D, Donadello K, Sakr Y, Ospina-Tascon G, Salgado D, Scolletta S, Vincent JL. Microcirculatory alterations in patients with severe sepsis: impact of time of assessment and relationship with outcome. Crit Care Med. 2013 Mar;41(3):791-9. doi: 10.1097/CCM.0b013e3182742e8b.

  PMID: 23318492 BACKGROUND

• Bruno RR, Wollborn J, Fengler K, Flick M, Wunder C, Allgauer S, Thiele H, Schemmelmann M, Hornemann J, Moecke HME, Demirtas F, Palici L, Franz M, Saugel B, Kattan E, De Backer D, Bakker J, Hernandez G, Kelm M, Jung C. Direct assessment of microcirculation in shock: a randomized-controlled multicenter study. Intensive Care Med. 2023 Jun;49(6):645-655. doi: 10.1007/s00134-023-07098-5. Epub 2023 Jun 6.

  PMID: 37278760 BACKGROUND

• Ince C. Hemodynamic coherence and the rationale for monitoring the microcirculation. Crit Care. 2015;19 Suppl 3(Suppl 3):S8. doi: 10.1186/cc14726. Epub 2015 Dec 18.

  PMID: 26729241 BACKGROUND

• Evans L, Rhodes A, Alhazzani W, Antonelli M, Coopersmith CM, French C, Machado FR, Mcintyre L, Ostermann M, Prescott HC, Schorr C, Simpson S, Wiersinga WJ, Alshamsi F, Angus DC, Arabi Y, Azevedo L, Beale R, Beilman G, Belley-Cote E, Burry L, Cecconi M, Centofanti J, Coz Yataco A, De Waele J, Dellinger RP, Doi K, Du B, Estenssoro E, Ferrer R, Gomersall C, Hodgson C, Moller MH, Iwashyna T, Jacob S, Kleinpell R, Klompas M, Koh Y, Kumar A, Kwizera A, Lobo S, Masur H, McGloughlin S, Mehta S, Mehta Y, Mer M, Nunnally M, Oczkowski S, Osborn T, Papathanassoglou E, Perner A, Puskarich M, Roberts J, Schweickert W, Seckel M, Sevransky J, Sprung CL, Welte T, Zimmerman J, Levy M. Surviving sepsis campaign: international guidelines for management of sepsis and septic shock 2021. Intensive Care Med. 2021 Nov;47(11):1181-1247. doi: 10.1007/s00134-021-06506-y. Epub 2021 Oct 2. No abstract available.

  PMID: 34599691 BACKGROUND

• Kuttab HI, Lykins JD, Hughes MD, Wroblewski K, Keast EP, Kukoyi O, Kopec JA, Hall S, Ward MA. Evaluation and Predictors of Fluid Resuscitation in Patients With Severe Sepsis and Septic Shock. Crit Care Med. 2019 Nov;47(11):1582-1590. doi: 10.1097/CCM.0000000000003960.

  PMID: 31393324 BACKGROUND

• Rhodes A, Evans LE, Alhazzani W, Levy MM, Antonelli M, Ferrer R, Kumar A, Sevransky JE, Sprung CL, Nunnally ME, Rochwerg B, Rubenfeld GD, Angus DC, Annane D, Beale RJ, Bellinghan GJ, Bernard GR, Chiche JD, Coopersmith C, De Backer DP, French CJ, Fujishima S, Gerlach H, Hidalgo JL, Hollenberg SM, Jones AE, Karnad DR, Kleinpell RM, Koh Y, Lisboa TC, Machado FR, Marini JJ, Marshall JC, Mazuski JE, McIntyre LA, McLean AS, Mehta S, Moreno RP, Myburgh J, Navalesi P, Nishida O, Osborn TM, Perner A, Plunkett CM, Ranieri M, Schorr CA, Seckel MA, Seymour CW, Shieh L, Shukri KA, Simpson SQ, Singer M, Thompson BT, Townsend SR, Van der Poll T, Vincent JL, Wiersinga WJ, Zimmerman JL, Dellinger RP. Surviving Sepsis Campaign: International Guidelines for Management of Sepsis and Septic Shock: 2016. Intensive Care Med. 2017 Mar;43(3):304-377. doi: 10.1007/s00134-017-4683-6. Epub 2017 Jan 18.

  PMID: 28101605 BACKGROUND

• Dellinger RP. The Surviving Sepsis Campaign: Where have we been and where are we going? Cleve Clin J Med. 2015 Apr;82(4):237-44. doi: 10.3949/ccjm.82gr.15001.

  PMID: 25955458 BACKGROUND

• Schorr CA, Zanotti S, Dellinger RP. Severe sepsis and septic shock: management and performance improvement. Virulence. 2014 Jan 1;5(1):190-9. doi: 10.4161/viru.27409. Epub 2013 Dec 11.

  PMID: 24335487 BACKGROUND

• Levy MM, Rhodes A, Phillips GS, Townsend SR, Schorr CA, Beale R, Osborn T, Lemeshow S, Chiche JD, Artigas A, Dellinger RP. Surviving Sepsis Campaign: association between performance metrics and outcomes in a 7.5-year study. Crit Care Med. 2015 Jan;43(1):3-12. doi: 10.1097/CCM.0000000000000723.

  PMID: 25275252 BACKGROUND

• Singer M, Deutschman CS, Seymour CW, Shankar-Hari M, Annane D, Bauer M, Bellomo R, Bernard GR, Chiche JD, Coopersmith CM, Hotchkiss RS, Levy MM, Marshall JC, Martin GS, Opal SM, Rubenfeld GD, van der Poll T, Vincent JL, Angus DC. The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA. 2016 Feb 23;315(8):801-10. doi: 10.1001/jama.2016.0287.

  PMID: 26903338 BACKGROUND

• Mouncey PR, Osborn TM, Power GS, Harrison DA, Sadique MZ, Grieve RD, Jahan R, Harvey SE, Bell D, Bion JF, Coats TJ, Singer M, Young JD, Rowan KM; ProMISe Trial Investigators. Trial of early, goal-directed resuscitation for septic shock. N Engl J Med. 2015 Apr 2;372(14):1301-11. doi: 10.1056/NEJMoa1500896. Epub 2015 Mar 17.

  PMID: 25776532 BACKGROUND

• ARISE Investigators; ANZICS Clinical Trials Group; Peake SL, Delaney A, Bailey M, Bellomo R, Cameron PA, Cooper DJ, Higgins AM, Holdgate A, Howe BD, Webb SA, Williams P. Goal-directed resuscitation for patients with early septic shock. N Engl J Med. 2014 Oct 16;371(16):1496-506. doi: 10.1056/NEJMoa1404380. Epub 2014 Oct 1.

  PMID: 25272316 BACKGROUND

• ProCESS Investigators; Yealy DM, Kellum JA, Huang DT, Barnato AE, Weissfeld LA, Pike F, Terndrup T, Wang HE, Hou PC, LoVecchio F, Filbin MR, Shapiro NI, Angus DC. A randomized trial of protocol-based care for early septic shock. N Engl J Med. 2014 May 1;370(18):1683-93. doi: 10.1056/NEJMoa1401602. Epub 2014 Mar 18.

  PMID: 24635773 BACKGROUND

• Rivers E, Nguyen B, Havstad S, Ressler J, Muzzin A, Knoblich B, Peterson E, Tomlanovich M; Early Goal-Directed Therapy Collaborative Group. Early goal-directed therapy in the treatment of severe sepsis and septic shock. N Engl J Med. 2001 Nov 8;345(19):1368-77. doi: 10.1056/NEJMoa010307.

  PMID: 11794169 BACKGROUND

MeSH Terms

Conditions

Sepsis; Intraabdominal Infections

Interventions

Ringer's acetate

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Changhong Miao, MD

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jian Huang, MD

CONTACT

+8618018684575; huang.jian1@zs-hospital.sh.cn

Jing Zhong, MD

CONTACT

+86-021-64041990; zhong.jing@zs-hospital.sh.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This trial uses a double-blind design. Participants, treating clinicians, investigators, outcome assessors, and statisticians are all blinded to treatment allocation. To ensure masking, study fluids are packaged in identical opaque containers, prepared and labeled by independent unblinded coordinators who are not involved in subject recruitment, clinical intervention, follow-up, or data analysis. A double-check system involving an independent witness is implemented during the drug packaging and labeling process. Strict role isolation is maintained throughout the study to prevent any bias in treatment execution or outcome assessment. Emergency unblinding is strictly limited to patient safety emergencies and must be documented.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a prospective, multicenter, double-blind, randomized controlled clinical trial with a parallel assignment design. Eligible patients will be randomized in a 1:1 ratio to receive either balanced gelatin solution or crystalloid solution as the primary resuscitation fluid during emergency abdominal surgery for sepsis. Randomization is stratified by baseline lactate level (≤4 vs. \>4 mmol/L) using a central dynamic allocation system.

Study Record Dates

• First Submitted: September 3, 2025
• First Posted: September 15, 2025
• Study Start: February 13, 2026
• Primary Completion (Estimated): September 30, 2028
• Study Completion (Estimated): December 30, 2028
• Last Updated: March 20, 2026

Record last verified: 2026-03

Locations

CN (9)