Intraoperative Different Fluid Therapy Protocols

NCT ID: NCT06188299

Last Updated: 2024-07-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-20

Study Completion Date

2023-05-15

Brief Summary

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

Detailed Description

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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).

Conditions

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Intraoperative Fluid Management

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Liberal Fluid Therapy Group and Targeted Fluid Therapy Groups.
Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Liberal Group Therapy

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

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type OTHER

Restricted Fluid Administration

Intervention Type 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.

Interventions

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Restricted 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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Planned pancreatic surgery
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ankara City Hospital Bilkent

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Ankara Bilkent Şehir Hastanesi

Ankara, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 33522953 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30919134 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33521643 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27828823 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20705785 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30945088 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35990294 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27788791 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28762023 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32205547 (View on PubMed)

Other Identifiers

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E2-21-1078

Identifier Type: -

Identifier Source: org_study_id

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