NephrectomyNCT06256120
Effect of Fluid Regimen on Acute Kidney Injury
A study testing Restrictive and Liberal in people with Nephrectomy and Acute Kidney Injury, run by Muğla Sıtkı Koçman University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Nephrectomy, Acute Kidney Injury, Fluid Therapy
- What is being tested?
- Restrictive and Liberal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 29 May 2024to 20 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiologists (ASA) I-II-III,
- The opposite kidney is in normal function
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Mugla Sitki Kocman Training and Research Hospital
Muğla, 48000
About this study
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
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.
Read the 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.
- Conditions
- Nephrectomy, Acute Kidney Injury, Fluid Therapy
- Being tested
- Restrictive, Liberal
- Keywords
- Nephrectomy, Acute Kidney Injury, Cystatin, Fluid treatment
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RestrictiveDiagnostic test
3 mL/kg/hour Ringer Lactate will be given peroperatively to the restrictive group (Group R).
LiberalDiagnostic test
7 ml/kg/hour Ringer Lactate will be given peroperatively to the liberal group (Group L).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). Receives: Diagnostic Test: Liberal |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 48 hour
Secondary outcomes (1)
Creatinine
Comparison of creatinine elevation between two groups
Measured: 48 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2024
- Study start29 May 2024
- Primary completion15 Jun 2024
- Study completion20 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for NephrectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Muğla Sıtkı Koçman University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eylem Yaşar, Muğla Sıtkı Koçman University
- Investigators
- Eylem Yasar, M.D, Principal investigator, Mugla Sitki Kocman Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06256120
- Sponsor's protocol ID
- Mugla SKU
- Status last verified
- Nov 2024
- First submitted
- 26 Dec 2023
- Last updated
- 26 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All data, except patient names, will be shared with the editor upon request after the article is accepted.
Publications
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.
PubMed 41146149
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06256120
- Acronym / sponsor ID
- Mugla SKU
- Conditions
- Nephrectomy, Acute Kidney Injury, Fluid Therapy
- Keywords
- Nephrectomy, Acute Kidney Injury, Cystatin, Fluid treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Muğla Sıtkı Koçman UniversityUniversity, hospital or other
- Study start
- 29 May 2024 (actual)
- Primary completion
- 15 Jun 2024 (actual)
- Study completion
- 20 Jun 2024 (actual)
- First posted
- 13 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| R- fluid group | Experimental | Diagnostic Test: RestrictiveThe group to which restrictive fluid replacement will be applied (Group R); 3 ml/kg/hour Ringer lactate (RL) solution will be given. |
| L- fluid group | Experimental | Diagnostic Test: Liberal7 ml/kg/hour RL solution will be given to the group that will receive a liberal liquid regimen (Group L). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- American Society of Anesthesiologists (ASA) I-II-III,
- The opposite kidney is in normal function
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Restrictive3 mL/kg/hour Ringer Lactate will be given peroperatively to the restrictive group (Group R). | Diagnostic test | R- fluid group |
| Liberal7 ml/kg/hour Ringer Lactate will be given peroperatively to the liberal group (Group L). | Diagnostic test | L- fluid group |
Primary outcome
rate of acute renal failure
Time frame: 48 hour
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.
1 secondary outcome
Creatinine
Time frame: 48 hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2024.
- Derived from this study: PubMed 41146149Yasar 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.
- Individual participant dataSharing planned: No. All data, except patient names, will be shared with the editor upon request after the article is accepted.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eylem Yasar, M.D principal investigator
Mugla Sitki Kocman Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Restrictive and Liberal in people with Nephrectomy and Acute Kidney Injury, run by Muğla Sıtkı Koçman University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
rate of acute renal failure (time frame: 48 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06256120, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2024.