Intraoperative Different Fluid Therapy Protocols

NCT06188299 | Completed

• 1 other identifier: E2-21-1078
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

We aimed to evaluate the relationship between different intraoperative fluid therapy protocols and postoperative renal damage and mortality.

Conditions

Intraoperative Fluid Management

Keywords

Liberal Fluid Therapy; Restrictive Fluid Therapy

Outcome Measures

Primary Outcomes (2)

• AKI

  Postoperative Renal Injury

  72 Hour

• Mortality

  Intraoperative and Postoperative Mortality Rate

  72 Hour

Secondary Outcomes (1)

• Blood Loss

  Intraoperative period

Study Arms (2)

Liberal Group Therapy

NO INTERVENTION

Liberal Fluid Therapy was administered to this group. Fluid restrictions were not used.

Targeted Fluid Therapy

OTHER

Targeted (restrictive) Fluid therapy was administered to this group. Fluids were given according to targeted blood pressure levels and aimed to avoid from fluid overload.

Other: Restricted Fluid Administration

Interventions

Restricted Fluid Administration OTHER

Restrictive fluid administration generally consists of partial or no replacement for the intravascular expansion from anesthesia, in which case vasopressors are usually administered, no replacement for the third space loss, and only partial replacement for deficits from preoperative fasting.

Targeted Fluid Therapy

Eligibility Criteria

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

You may qualify if:

• Planned pancreatic surgery

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Study Sites (1)

Ankara Bilkent Şehir Hastanesi

Ankara, 06660, Turkey (Türkiye)

Location

Related Publications (10)

• Messina A, Robba C, Calabro L, Zambelli D, Iannuzzi F, Molinari E, Scarano S, Battaglini D, Baggiani M, De Mattei G, Saderi L, Sotgiu G, Pelosi P, Cecconi M. Association between perioperative fluid administration and postoperative outcomes: a 20-year systematic review and a meta-analysis of randomized goal-directed trials in major visceral/noncardiac surgery. Crit Care. 2021 Feb 1;25(1):43. doi: 10.1186/s13054-021-03464-1.

  PMID: 33522953 BACKGROUND

• Oh TK, Song IA, Do SH, Jheon S, Lim C. Association of perioperative weight-based fluid balance with 30-day mortality and acute kidney injury among patients in the surgical intensive care unit. J Anesth. 2019 Jun;33(3):354-363. doi: 10.1007/s00540-019-02630-8. Epub 2019 Mar 27.

  PMID: 30919134 BACKGROUND

• Bihari S, Dixon DL, Painter T, Myles P, Bersten AD. Understanding Restrictive Versus Liberal Fluid Therapy for Major Abdominal Surgery Trial Results: Did Liberal Fluids Associate With Increased Endothelial Injury Markers? Crit Care Explor. 2021 Jan 25;3(1):e0316. doi: 10.1097/CCE.0000000000000316. eCollection 2021 Jan.

  PMID: 33521643 BACKGROUND

• Mason SA, Nathens AB, Finnerty CC, Gamelli RL, Gibran NS, Arnoldo BD, Tompkins RG, Herndon DN, Jeschke MG; Inflammation and the Host Response to Injury Collaborative Research Program.. Hold the Pendulum: Rates of Acute Kidney Injury are Increased in Patients Who Receive Resuscitation Volumes Less than Predicted by the Parkland Equation. Ann Surg. 2016 Dec;264(6):1142-1147. doi: 10.1097/SLA.0000000000001615.

  PMID: 27828823 BACKGROUND

• Forget P, Lois F, de Kock M. Goal-directed fluid management based on the pulse oximeter-derived pleth variability index reduces lactate levels and improves fluid management. Anesth Analg. 2010 Oct;111(4):910-4. doi: 10.1213/ANE.0b013e3181eb624f. Epub 2010 Aug 12.

  PMID: 20705785 BACKGROUND

• Gottin L, Martini A, Menestrina N, Schweiger V, Malleo G, Donadello K, Polati E. Perioperative Fluid Administration in Pancreatic Surgery: a Comparison of Three Regimens. J Gastrointest Surg. 2020 Mar;24(3):569-577. doi: 10.1007/s11605-019-04166-4. Epub 2019 Apr 3.

  PMID: 30945088 BACKGROUND

• Yilmaz G, Akca A, Kiyak H, Can E, Aydin A, Salihoglu Z. Pleth Variability Index-Based Goal-Directed Fluid Management in Patients Undergoing Elective Gynecologic Surgery. Sisli Etfal Hastan Tip Bul. 2022 Jun 28;56(2):220-226. doi: 10.14744/SEMB.2021.81073. eCollection 2022.

  PMID: 35990294 BACKGROUND

• Collange O, Jazaerli L, Lejay A, Biermann C, Caillard S, Moulin B, Chakfe N, Severac F, Schaeffer M, Mertes PM, Steib A. Intraoperative Pleth Variability Index Is Linked to Delayed Graft Function After Kidney Transplantation. Transplant Proc. 2016 Oct;48(8):2615-2621. doi: 10.1016/j.transproceed.2016.06.046.

  PMID: 27788791 BACKGROUND

• Demirel I, Bolat E, Altun AY, Ozdemir M, Bestas A. Efficacy of Goal-Directed Fluid Therapy via Pleth Variability Index During Laparoscopic Roux-en-Y Gastric Bypass Surgery in Morbidly Obese Patients. Obes Surg. 2018 Feb;28(2):358-363. doi: 10.1007/s11695-017-2840-1.

  PMID: 28762023 BACKGROUND

• Fischer MO, Lemoine S, Tavernier B, Bouchakour CE, Colas V, Houard M, Greub W, Daccache G, Hulet C, Compere V, Taing D, Lorne E, Parienti JJ, Hanouz JL; Optimization using the Pleth Variability Index (OPVI) Trial Group. Individualized Fluid Management Using the Pleth Variability Index: A Randomized Clinical Trial. Anesthesiology. 2020 Jul;133(1):31-40. doi: 10.1097/ALN.0000000000003260.

  PMID: 32205547 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Liberal Fluid Therapy Group and Targeted Fluid Therapy Groups.

Study Record Dates

• First Submitted: December 18, 2023
• First Posted: January 3, 2024
• Study Start: January 20, 2022
• Primary Completion: December 1, 2022
• Study Completion: May 15, 2023
• Last Updated: July 17, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)