Proactive Hemodynamic Management During Cytoreductive Surgery and HIPEC

NCT07070973 | Not Yet Recruiting

• 1 other identifier: 7488
• Study Type: interventional
• Target: 52
• Locations: 0 countries
• Sites: N/A

Brief Summary

Cytoreductive surgery (CRS) with hyperthermic intraperitoneal chemotherapy (HIPEC) is a complex surgical procedure carried out through laparotomic approach. After CRS-HIPEC morbidity and mortality rates go up to 20%-40% and 3% respectively, and acute kidney injury and pulmonary effusion/oedema are the most frequent postoperative complications. Intraoperative hypotension and risk of fluid overload are common. Efficient and accurate control of arterial pressure and cardiac output is a major concern during CRS-HIPEC. The aim of this study is to perform a pilot study describing a hemodynamic management protocol based on artificial intelligence - derived parameters, that allows to implement the standard goal directed therapy (GDT) protocol in term of amount of IOH and stroke volume (SV) optimization. Specifically, this study aims to test the hypotheses that a hemodynamic protocol based on HPI-AFM monitoring compared to standard GDT helps clinicians reduce IOH during surgery and improve the time "in-target" range of SV index. The study cohort will be compared to an historical cohort of 50 patients underwent to CRS-HIPEC between 2022 and 2024, managed with an institutional goal directed therapy protocol.

Conditions

Ovarian Cancer; Hemodynamic Instability; Fluid Overload

Outcome Measures

Primary Outcomes (2)

• TWA-MAP<65mmHg

  We intend to define two hierarchical primary endpoints. The first primary endpoint will be the time-weighted average (TWA) - MAP less than 65 mmHg (expressed in mmHg) throughout surgery. The second primary endpoint will be the time spent during surgery in an optimized range of SVI (the "in target" range will be defined at the beginning of hemodynamic monitoring). The optimized range of SVI is the range between the patient's baseline SVI rate and the SVI obteined after a 250 ml fluid bolus.

  Perioperative

• TIT-SVI

  We intend to define two hierarchical primary endpoints. The first primary endpoint will be the time-weighted average (TWA) - MAP less than 65 mmHg (expressed in mmHg) throughout surgery. The second primary endpoint will be the time spent during surgery in an optimized range of SVI (the "in target" range will be defined at the beginning of hemodynamic monitoring). The optimized range of SVI is the range between the patient's baseline SVI rate and the SVI obteined after a 250 ml fluid bolus.

  Perioperative

Secondary Outcomes (2)

• Vasopressors

  Perioperative

• Fluids

  Perioperative

Other Outcomes (3)

• AFM effectiveness

  Perioperative

• PPCs

  Up to one month from the day of surgery

• Hospital costs

  At discharge to home

Study Arms (2)

Proactive monitoring

EXPERIMENTAL

The patients will be managed following an algorithm based on Assisted Fluid Management (AFM) for fluid infusion and on Hypotension Prediction Index (HPI) to titrate vasopressors and inotropes. AFM will be set as "medium" during cytoreductive phase and "restrictive" during HIPEC.

Device: Assisted Fluid Management

Goal Directed Fluid Therapy (GDT)

ACTIVE COMPARATOR

The patients have been managed following institutional algorithm aimed to optimize stroke volume index and reduce intraoperative hypotension

Other: Goal Directed Fluid Therapy (GDT)

Interventions

Assisted Fluid Management DEVICE

Intraoperative fluid infusion will be regulated according to the Assisted Fluid Management (AFM) software and on Hypotension Prediction Index (HPI) will be used to titrate vasopressors and inotropes.

Proactive monitoring

Goal Directed Fluid Therapy (GDT) OTHER

Institutional goal directed therapy protocol used to optimize SVI and reduce intraoperative hypotension

Goal Directed Fluid Therapy (GDT)

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Patients affected by ovarian cancer
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age \> 18 years
• patient scheduled for CRS for ovarian cancer

You may not qualify if:

• patients' refusal
• cardiac arrythmia
• pregnancy.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Related Publications (14)

• van Driel WJ, Koole SN, Sikorska K, Schagen van Leeuwen JH, Schreuder HWR, Hermans RHM, de Hingh IHJT, van der Velden J, Arts HJ, Massuger LFAG, Aalbers AGJ, Verwaal VJ, Kieffer JM, Van de Vijver KK, van Tinteren H, Aaronson NK, Sonke GS. Hyperthermic Intraperitoneal Chemotherapy in Ovarian Cancer. N Engl J Med. 2018 Jan 18;378(3):230-240. doi: 10.1056/NEJMoa1708618.

  PMID: 29342393 RESULT

• Ghirardi V, Trozzi R, Scanu FR, Giannarelli D, Santullo F, Costantini B, Naldini A, Panico C, Frassanito L, Scambia G, Fagotti A. Expanding the Use of HIPEC in Ovarian Cancer at Time of Interval Debulking Surgery to FIGO Stage IV and After 6 Cycles of Neoadjuvant Chemotherapy: A Prospective Analysis on Perioperative and Oncologic Outcomes. Ann Surg Oncol. 2024 May;31(5):3350-3360. doi: 10.1245/s10434-024-15042-0. Epub 2024 Feb 27.

  PMID: 38411761 RESULT

• Wang JY, Gross M, Urban RR, Jorge S. Intraperitoneal and Hyperthermic Intraperitoneal Chemotherapy for the Treatment of Ovarian Cancer. Curr Treat Options Oncol. 2024 Mar;25(3):313-329. doi: 10.1007/s11864-023-01171-3. Epub 2024 Jan 4.

  PMID: 38270801 RESULT

• Kajdi ME, Beck-Schimmer B, Held U, Kofmehl R, Lehmann K, Ganter MT. Anaesthesia in patients undergoing cytoreductive surgery with hyperthermic intraperitoneal chemotherapy: retrospective analysis of a single centre three-year experience. World J Surg Oncol. 2014 May 1;12:136. doi: 10.1186/1477-7819-12-136.

  PMID: 24886171 RESULT

• Mendonca FT, Guimaraes MM, de Matos SH, Dusi RG. Anesthetic management of Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy (CRS/HIPEC): The importance of hydro-electrolytic and acid-basic control. Int J Surg Case Rep. 2017;38:1-4. doi: 10.1016/j.ijscr.2017.07.011. Epub 2017 Jul 10.

  PMID: 28719887 RESULT

• Esteve-Perez N, Ferrer-Robles A, Gomez-Romero G, Fabian-Gonzalez D, Verd-Rodriguez M, Mora-Fernandez LC, Segura-Sampedro JJ, Tejada-Gavela S, Morales-Soriano R. Goal-directed therapy in cytoreductive surgery with hyperthermic intraperitoneal chemotherapy: a prospective observational study. Clin Transl Oncol. 2019 Apr;21(4):451-458. doi: 10.1007/s12094-018-1944-y. Epub 2018 Sep 14.

  PMID: 30218305 RESULT

• Lim MC, Chang SJ, Park B, Yoo HJ, Yoo CW, Nam BH, Park SY; HIPEC for Ovarian Cancer Collaborators. Survival After Hyperthermic Intraperitoneal Chemotherapy and Primary or Interval Cytoreductive Surgery in Ovarian Cancer: A Randomized Clinical Trial. JAMA Surg. 2022 May 1;157(5):374-383. doi: 10.1001/jamasurg.2022.0143.

  PMID: 35262624 RESULT

• Frassanito L, Giuri PP, Vassalli F, Piersanti A, Garcia MIM, Sonnino C, Zanfini BA, Catarci S, Antonelli M, Draisci G. Hypotension Prediction Index guided Goal Directed therapy and the amount of Hypotension during Major Gynaecologic Oncologic Surgery: a Randomized Controlled clinical Trial. J Clin Monit Comput. 2023 Aug;37(4):1081-1093. doi: 10.1007/s10877-023-01017-1. Epub 2023 Apr 29.

  PMID: 37119322 RESULT

• Desale MG, Tanner EJ 3rd, Sinno AK, Angarita AA, Fader AN, Stone RL, Levinson KL, Bristow RE, Roche KL. Perioperative fluid status and surgical outcomes in patients undergoing cytoreductive surgery for advanced epithelial ovarian cancer. Gynecol Oncol. 2016 Oct 28:S0090-8258(16)31501-3. doi: 10.1016/j.ygyno.2016.10.027. Online ahead of print.

  PMID: 28029449 RESULT

• Bossy M, Nyman M, Madhuri TK, Tailor A, Chatterjee J, Butler-Manuel S, Ellis P, Feldheiser A, Creagh-Brown B. The need for post-operative vasopressor infusions after major gynae-oncologic surgery within an ERAS (Enhanced Recovery After Surgery) pathway. Perioper Med (Lond). 2020 Sep 7;9:26. doi: 10.1186/s13741-020-00158-0. eCollection 2020.

  PMID: 32939254 RESULT

• Pearse RM, Harrison DA, MacDonald N, Gillies MA, Blunt M, Ackland G, Grocott MP, Ahern A, Griggs K, Scott R, Hinds C, Rowan K; OPTIMISE Study Group. Effect of a perioperative, cardiac output-guided hemodynamic therapy algorithm on outcomes following major gastrointestinal surgery: a randomized clinical trial and systematic review. JAMA. 2014 Jun 4;311(21):2181-90. doi: 10.1001/jama.2014.5305.

  PMID: 24842135 RESULT

• Joosten A, Hafiane R, Pustetto M, Van Obbergh L, Quackels T, Buggenhout A, Vincent JL, Ickx B, Rinehart J. Practical impact of a decision support for goal-directed fluid therapy on protocol adherence: a clinical implementation study in patients undergoing major abdominal surgery. J Clin Monit Comput. 2019 Feb;33(1):15-24. doi: 10.1007/s10877-018-0156-x. Epub 2018 May 19.

  PMID: 29779129 RESULT

• Maheshwari K, Malhotra G, Bao X, Lahsaei P, Hand WR, Fleming NW, Ramsingh D, Treggiari MM, Sessler DI, Miller TE; Assisted Fluid Management Study Team. Assisted Fluid Management Software Guidance for Intraoperative Fluid Administration. Anesthesiology. 2021 Aug 1;135(2):273-283. doi: 10.1097/ALN.0000000000003790.

  PMID: 33901281 RESULT

• Wijnberge M, Geerts BF, Hol L, Lemmers N, Mulder MP, Berge P, Schenk J, Terwindt LE, Hollmann MW, Vlaar AP, Veelo DP. Effect of a Machine Learning-Derived Early Warning System for Intraoperative Hypotension vs Standard Care on Depth and Duration of Intraoperative Hypotension During Elective Noncardiac Surgery: The HYPE Randomized Clinical Trial. JAMA. 2020 Mar 17;323(11):1052-1060. doi: 10.1001/jama.2020.0592.

  PMID: 32065827 RESULT

MeSH Terms

Conditions

Ovarian Neoplasms; Edema

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Luciano Frassanito

  Fondazione Policlinico Universitario A. Gemelli, IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Luciano Frassanito, MD

CONTACT

+393475256158; luciano.frassanito@policlinicogemelli.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Intention to treat

Study Record Dates

• First Submitted: June 30, 2025
• First Posted: July 17, 2025
• Study Start: September 1, 2025
• Primary Completion: November 30, 2025
• Study Completion: December 31, 2025
• Last Updated: August 11, 2025

Record last verified: 2025-07