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

NCT06408597 | Active Not Recruiting

• 1 other identifier: MVTKIPRARPC
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Prostate Cancer; Bladder Cancer; Surgery; Renal Impairment; Renal Injury, Acute

Keywords

Radical Prostatectomy; Radical Cystectomy; Robotic; Anesthesia; Mannitol; Nitroglycerin

Outcome Measures

Primary Outcomes (1)

• Cystatin C level

  Serum Cystatin C value in mg/l

  24 hours

Study Arms (3)

Control group

ACTIVE COMPARATOR

Standard Fluid Therapy group

Procedure: Fluid Regimen

Nitroglycerin group

EXPERIMENTAL

Nitroglycerin Infusion group

Procedure: Nitroglycerin Infusion; Procedure: Fluid Regimen

Mannitol group

EXPERIMENTAL

Mannitol Infusion group

Procedure: Mannitol Infusion; Procedure: Fluid Regimen

Interventions

Nitroglycerin Infusion PROCEDURE

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.

Nitroglycerin group

Mannitol Infusion PROCEDURE

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.

Mannitol group

Fluid Regimen PROCEDURE

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.

Control group; Mannitol group; Nitroglycerin 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:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nazmy Edward Seif: lead

Study Sites (1)

Cairo University Hospitals

Cairo, Egypt

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Urinary Bladder Neoplasms; Renal Insufficiency; Acute Kidney Injury

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Urologic Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urinary Bladder Diseases; Urologic Diseases; Kidney Diseases

Study Officials

• Ashgan R Ali, MD

  Kasr Al-Ainy Hospital, Faculty of Medicine, Cairo University

  STUDY CHAIR

• Nazmy S Mikhael, MD

  Kasr Al-Ainy Hospital, Faculty of Medicine, Cairo University

  PRINCIPAL INVESTIGATOR

• Manar H Mohamed

  Kasr Al-Ainy Hospital, Faculty of Medicine, Cairo University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: May 7, 2024
• First Posted: May 10, 2024
• Study Start: May 12, 2024
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: March 18, 2026

Record last verified: 2026-03

Locations

EG (1)