Mannitol Versus Nitroglycerin for Kidney Injury Prevention in Robotic-assisted Radical Prostatectomy or Cystectomy

March 16, 2026 updated by: Nazmy Edward Seif

The Use of Intra-operative Mannitol Versus Nitroglycerin to Prevent Post-operative Acute Kidney Injury in Patients Undergoing Robotic-assisted Radical Prostatectomy or Cystectomy: A Randomized Controlled Trial.

Laparoscopic and minimally-invasive robotic access has transformed the delivery of urological surgery. While associated with numerous desirable outcomes including shorter post-operative stay and faster return to preoperative function, these techniques have also been associated with morbidity such as reduced renal blood flow and post-operative renal dysfunction. The mechanisms leading to these renal effects complex are multifactorial, and have not been fully elucidated. However they are likely to include direct effects from raised intra-abdominal pressure, and indirect effects secondary to carbon dioxide absorption, neuroendocrine factors and tissue damage from oxidative stress. It is well documented that pneumoperitoneum places profound stress on the cardiovascular, respiratory and gastrointestinal systems; it also places strain on the renal system.

During robotic surgery, continuous pneumoperitoneum and continuous rising of intra-abdominal pressure causes transient oliguria. Moreover, kidney function, estimated by the GFR, deteriorates during elevated intra abdominal pressure (IAP), and most of the studies identified decrease in renal blood flow (RBF) and renal cortical perfusion.

Studies conducted to assess the contribution of the nitric oxide (NO) system to the renal hemodynamic/function alterations during pneumoperitoneum, concluded that these adverse effects are probably related to interference with the NO system, and could be partially ameliorated by pretreatment with nitroglycerine.

Mannitol is an osmotic diuretic and a renal vasodilator that promotes tubular flow, prevents intratubular cast formation, decreases postischemic cellular swelling, and might serve as a free radical scavenger. Mannitol has traditionally been administered before renal surgeries to minimize perioperative renal dysfunction according to preclinical animal studies and clinical experience with renal transplantation. However, high-level clinical data in support of this belief are not available.

The aim of this study is to characterize the effects of increased intra-abdominal pressure on renal perfusion and function in cases undergoing robotic lower tract urologic surgeries, and to assess the contribution of either mannitol or nitroglycerin infusion to the renal hemodynamic/function alterations during pneumoperitoneum.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • Cairo University Hospitals

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • ASA class I - III
  • Normal renal functions or Mild renal disease (GFR < 60 ml/min &/or presence of albuminuria > 30 mg/dl)

Exclusion Criteria:

  • BMI > 40
  • Previous renal surgery
  • Moderate (GFR 30 - 59 mg/dl) & severe (GFR 15 - 29 mg/dl) renal impairment
  • Decompensated cardiac disease: New York Heart Association (NYHA) class 3 or 4
  • Allergy to mannitol or nitroglycerin

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control group
Standard Fluid Therapy group
Procedure: Fluid Regimen

Patients will take the standard fluid chart, as the patient will receive the estimated maintenance & deficit requirements according to 4/2/1 rule.

In case of hypotension, (defined as 20% decrease from the baseline), administration of a fluid bolus of 200 ml ringer will be done.

Blood loss more than 10% of estimated blood volume will initiate blood transfusion using 1:1 ratio. Additional fluids may be administered postoperatively according to the patient's volume status.
Experimental: Nitroglycerin group
Nitroglycerin Infusion group
Procedure: Fluid Regimen

Patients will take the standard fluid chart, as the patient will receive the estimated maintenance & deficit requirements according to 4/2/1 rule.

In case of hypotension, (defined as 20% decrease from the baseline), administration of a fluid bolus of 200 ml ringer will be done.

Blood loss more than 10% of estimated blood volume will initiate blood transfusion using 1:1 ratio. Additional fluids may be administered postoperatively according to the patient's volume status.

Procedure: Nitroglycerin Infusion

Nitroglycerin prepared using a vial (50 mg nitroglycerin) transferred into a 500 ml glass bottle of sodium chloride injection (0.9%), this yields a concentration of 100 mcg/ml.

Patients in the nitroglycerin group will receive nitroglycerin infusion at a rate of 0.25 mic/kg/min all through the surgery, to be discontinued in the PACU.
Experimental: Mannitol group
Mannitol Infusion group
Procedure: Fluid Regimen

Patients will take the standard fluid chart, as the patient will receive the estimated maintenance & deficit requirements according to 4/2/1 rule.

In case of hypotension, (defined as 20% decrease from the baseline), administration of a fluid bolus of 200 ml ringer will be done.

Blood loss more than 10% of estimated blood volume will initiate blood transfusion using 1:1 ratio. Additional fluids may be administered postoperatively according to the patient's volume status.

Procedure: Mannitol Infusion

Mannitol will be prepared through diluting 100 ml of the 20% solution with 180 ml of sodium chloride injection (0.9%).

Patients in the mannitol group will receive an infusion bolus of mannitol 20% 0.5gm/kg added to the standard fluid chart via centeral line.

Mannitol intake will be started directly after induction of anaesthesia and before intra-peritoneal gas insufflation, as an infusion over 15 minutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cystatin C level
Time Frame: 24 hours
Serum Cystatin C value in mg/l
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nazmy Edward Seif

Investigators

  • Study Chair: Ashgan R Ali, MD, Kasr Al-Ainy Hospital, Faculty of Medicine, Cairo University
  • Principal Investigator: Nazmy S Mikhael, MD, Kasr Al-Ainy Hospital, Faculty of Medicine, Cairo University
  • Study Director: Manar H Mohamed, Kasr Al-Ainy Hospital, Faculty of Medicine, Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 12, 2024

Primary Completion (Estimated)

May 1, 2026

Study Completion (Estimated)

May 1, 2026

Study Registration Dates

First Submitted

May 7, 2024

First Submitted That Met QC Criteria

May 7, 2024

First Posted (Actual)

May 10, 2024

Study Record Updates

Last Update Posted (Actual)

March 18, 2026

Last Update Submitted That Met QC Criteria

March 16, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MVTKIPRARPC

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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