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NCT06408597Active, not recruiting

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

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.

Source: ClinicalTrials.gov · Last updated 20 Oct 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Study type
Interventional
Enrollment
90 (estimated)
First submitted
7 May 2024
Start date
12 May 2024
Primary completion date
Nov 2026
Lead sponsor
Nazmy Edward Seif
NCT number
NCT06408597

What you commit to

  • Study type: Interventional
  • Planned participants: 90
  • From 12 May 2024 to the primary completion date, Nov 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Previous renal surgery

Other illness

  • Decompensated cardiac disease: New York Heart Association (NYHA) class 3 or 4
  • Allergy to mannitol or nitroglycerin

Lab values

  • Moderate (GFR 30 - 59 mg/dl) \& severe (GFR 15 - 29 mg/dl) renal impairment

Other

  • BMI \> 40

Who the study is looking for

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

Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Cairo University Hospitals
Coordinator of this site? Confirm its status
CairoEgyptUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.