Effect of Fluid Regimen on Acute Kidney Injury

NCT06256120 | Completed

• 1 other identifier: Mugla SKU
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Postoperative acute kidney injury (AKI) is an important surgical complication that increases hospital stay and mortality when it occurs after kidney surgery. Studies investigating the effects of restrictive or liberal fluid regimen on postoperative AKI during radical/partial nephrectomy have given controversial results. It is important to recognize AKI early so that supportive treatments can be started early. Serum creatinine level, which is frequently used in the detection of AKI, increases late and causes a delay in diagnosis. It has been reported that cystatin C level increases earlier than creatinine in the diagnosis of AKI, so it can be used for early diagnosis.

Conditions

Nephrectomy; Acute Kidney Injury; Fluid Therapy

Keywords

Nephrectomy; Acute Kidney Injury; Cystatin; Fluid treatment

Outcome Measures

Primary Outcomes (1)

• rate of acute renal failure

  To determine whether the restrictive or liberal fluid regimen applied during partial or radical nephrectomy surgery causes acute renal failure in the early postoperative period.

  48 hour

Secondary Outcomes (1)

• Creatinine

  48 hour

Study Arms (2)

R- fluid group

EXPERIMENTAL

The group to which restrictive fluid replacement will be applied (Group R); 3 ml/kg/hour Ringer lactate (RL) solution will be given.

Diagnostic Test: Restrictive

L- fluid group

EXPERIMENTAL

7 ml/kg/hour RL solution will be given to the group that will receive a liberal liquid regimen (Group L).

Diagnostic Test: Liberal

Interventions

Restrictive DIAGNOSTIC_TEST

3 mL/kg/hour Ringer Lactate will be given peroperatively to the restrictive group (Group R).

R- fluid group

Liberal DIAGNOSTIC_TEST

7 ml/kg/hour Ringer Lactate will be given peroperatively to the liberal group (Group L).

L- fluid group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• American Society of Anesthesiologists (ASA) I-II-III,
• The opposite kidney is in normal function

You may not qualify if:

• Those who are planned for bilateral partial nephrectomy,
• Patients with preoperative chronic kidney disease,
• Those using preoperative medications known to cause renal toxicity such as aminoglycosides, aspirin and angiotensin converting enzyme inhibitors,
• Coronary artery disease
• Congestive heart failure

Sponsors & Collaborators

• Muğla Sıtkı Koçman University: lead

Study Sites (1)

Mugla Sitki Kocman Training and Research Hospital

Muğla, 48000, Turkey (Türkiye)

Location

Related Publications (1)

• Yasar E, Toker MK, Saruhan E, Gursoy C. Impact of liberal versus restrictive fluid management on acute kidney injury after nephrectomy: a randomised controlled trial with cystatin C evaluation. BMC Urol. 2025 Oct 27;25(1):270. doi: 10.1186/s12894-025-01954-w.

  PMID: 41146149 DERIVED

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Eylem Yasar, M.D

  Mugla Sitki Kocman Training and Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Patients and those evaluating blood samples will not know which group they are in the study.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Patients will be randomly divided into two groups: restrictive and liberal fluid replacement groups. 3 ml/kg/hour Ringer's lactate (RL) solution will be given to the group that will receive restrictive fluid replacement (Group R), and 7 ml/kg/hour RL solution will be given to the group that will receive liberal fluid regimen (Group L). Patients in both groups will receive 1.5 ml/kg/hour crystalloid fluid replacement on postoperative day 1, and oral intake will be increased on day 2. Serum creatinine, GFR and blood urea nitrogen (BUN) values will be measured in all patients before surgery and 48 hours after removal of the renal pedicle clamp. Patients' blood and blood product replacement, vasopressor and inotrope needs will be recorded. Serum cystatin C level will be measured by taking serum samples before the surgery and at the 48th hour postoperatively.

Study Record Dates

• First Submitted: December 26, 2023
• First Posted: February 13, 2024
• Study Start: May 29, 2024
• Primary Completion: June 15, 2024
• Study Completion: June 20, 2024
• Last Updated: November 26, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)