Clinical trial NCT06256120: Effect of Fluid Regimen on Acute Kidney Injury
Official title: Effects of Peroperative Liberal and Restrictive Fluid Regimens on Protection From Postoperative Acute Kidney Injury in Patients Undergoing Partial or Radical Nephrectomy; Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nephrectomy
Acute Kidney Injury
Fluid Therapy
Keywords: Nephrectomy
Acute Kidney Injury
Cystatin
Fluid treatment
Lead sponsor: Muğla Sıtkı Koçman University
Sponsor class: OTHER
First posted: 2024-02-13
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: DIAGNOSTIC

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.

Detailed description: Hypovolemia and organ dysfunction may occur as a result of giving too little fluid during the operation; Giving too much fluid can also cause edema and organ damage. AKI, which develops after kidney surgery, is an important surgical complication and its incidence varies between 5.5% and 34%. Kidney damage is initially subclinical, and its detection is delayed with current diagnostic tools. Due to increased microvascular permeability as a result of excessive fluid administration during the operation, edema in organ tissues and systems may increase infection rates and kidney damage. In a study in which restrictive and free fluid was applied during abdominal aortic aneurysm surgery, they showed that there was deterioration in renal endothelial function in the liberal group; They found that the urine albumin/creatinine ratio increased. In another study, they reported that serum creatinine levels decreased on the first day in patients who underwent colorectal surgery in the group where they applied a liberal fluid regimen; However, they reported that they could not find a significant difference between them and the restrictive group on the following days. It has been shown that restrictive and liberal fluid management applied during abdominal surgery have no effect on renal functions. Although there are few studies in the literature showing that restrictive and liberal fluid regimens applied during abdominal operations affect postoperative renal functions; There are no studies investigating the ideal intraoperative fluid replacement in nephrectomy patients.

It is known that the serum creatinine level, which is routinely used to monitor renal functions, increases late and has poor sensitivity. The reason for this is that it begins to increase 48-72 hours after kidney damage begins and when 50% of functional neurons are lost. Cystatin C, produced by all nucleated cells, is freely filtered by the glomerulus and reabsorbed in the proximal tubule. It is not secreted by renal tubules and does not vary depending on gender, race, weight, changes in muscle mass and nutrition. Serum cystatin C is a biomarker that reflects glomerular filtration rate (GFR) well and can diagnose AKI more accurately than creatinine.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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

Primary outcomes:
measure: rate of acute renal failure
timeFrame: 48 hour
Secondary outcomes:
measure: Creatinine
timeFrame: 48 hour
Other outcomes:
Locations:
city: Mugla
country: Turkey
facility: Mugla Sitki Kocman Training and Research Hospital
Study officials:
affiliation: Mugla Sitki Kocman Training and Research Hospital
name: Eylem Yasar, M.D
role: PRINCIPAL_INVESTIGATOR
References: