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CompletedNCT06188299Updated Jul 17, 2024

Intraoperative Different Fluid Therapy Protocols

An interventional study of Restricted Fluid Administration in Intraoperative Fluid Management, sponsored by Ankara City Hospital Bilkent. Completed at 1 site in Turkey. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-07-17.

Sponsored by Ankara City Hospital Bilkent · Not applicable, Interventional, and Other

From the registry’s dates

  • Registered 1 year 10 months after the study started (first participant enrolled Jan 2022, registered Dec 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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

Read the detailed description

Sixty patients who 18-65 age and underwent pancreatic surgery in our hospital were included in the study. They were divided into two groups as liberal fluid therapy (Group 1, n=30) and targeted fluid therapy (Group 2, n=30).

02

Conditions studied

  • Intraoperative Fluid Management

Keywords

  • Liberal Fluid Therapy
  • Restrictive Fluid Therapy
03

In context

Lead sponsor

Ankara City Hospital Bilkent is the lead sponsor of 424 studies on the registry; 105 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Planned pancreatic surgery

Exclusion criteria

Exclusion Criteria:

  • No exclusion criteria was presetted.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
60 participants (actual)

Study arms

  • No intervention
    Liberal Group Therapy

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

  • Other
    Targeted Fluid Therapy

    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

  • OtherRestricted Fluid Administration

    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.

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What researchers measure

Primary outcomes

  1. AKI

    Postoperative Renal Injury

    Time frame: 72 Hour

  2. Mortality

    Intraoperative and Postoperative Mortality Rate

    Time frame: 72 Hour

Secondary outcomes

  1. Blood Loss

    Intraoperative total blood loss

    Time frame: Intraoperative period

07

Study locations

1 site
  • Ankara Bilkent Şehir Hastanesi
    Ankara, 06660, Turkey
08

References and documents

Publications

  • 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. PubMed 33522953 ↗
  • 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. PubMed 30919134 ↗
  • 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. PubMed 33521643 ↗
  • 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. PubMed 27828823 ↗
  • 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. PubMed 20705785 ↗
  • 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. PubMed 30945088 ↗
  • 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. PubMed 35990294 ↗
  • 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. PubMed 27788791 ↗
  • 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. PubMed 28762023 ↗
  • 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. PubMed 32205547 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 17, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06188299
Lead sponsor
Ankara City Hospital Bilkent
Responsible party
Sponsor
First posted
Jan 3, 2024
Start date
Jan 20, 2022
Primary completion
Dec 1, 2022
Completion
May 15, 2023
Last update
Jul 17, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.

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