Prostate CancerNCT06408597
Mannitol Versus Nitroglycerin for Kidney Injury Prevention in Robotic-assisted Radical Prostatectomy or Cystectomy
A study testing Nitroglycerin Infusion, Mannitol Infusion and Fluid Regimen in people with Prostate Cancer and Bladder Cancer, run by Nazmy Edward Seif at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Prostate Cancer, Bladder Cancer, Surgery
- What is being tested?
- Nitroglycerin Infusion, Mannitol Infusion and Fluid Regimen
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 12 May 2024to Nov 2026
- Phase
- Interventional
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
- ASA class I - III
- Normal renal functions or Mild renal disease (GFR < 60 ml/min \&/or presence of albuminuria > 30 mg/dl)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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
- Being tested
- Nitroglycerin Infusion, Mannitol Infusion, Fluid Regimen
- Keywords
- Radical Prostatectomy, Radical Cystectomy, Robotic, Anesthesia, Mannitol, Nitroglycerin
- Medical subject headings
- Prostatic Neoplasms, Urinary Bladder Neoplasms, Renal Insufficiency, Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nitroglycerin InfusionProcedure or surgery
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.
Mannitol InfusionProcedure or surgery
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.
Fluid RegimenProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | Standard Fluid Therapy group Receives: Procedure: Fluid Regimen |
| Nitroglycerin group | Experimental | Nitroglycerin Infusion group Receives: Procedure: Nitroglycerin Infusion; Procedure: Fluid Regimen |
| Mannitol group | Experimental | Mannitol Infusion group Receives: Procedure: Mannitol Infusion; Procedure: Fluid Regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cystatin C level
Serum Cystatin C value in mg/l
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2024
- Study start12 May 2024
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nazmy Edward Seif
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Nazmy Edward Seif, Cairo University
- Investigators
- Ashgan R Ali, MD, Study chair, Kasr Al-Ainy Hospital, Faculty of Medicine, Cairo UniversityNazmy S Mikhael, MD, Principal investigator, Kasr Al-Ainy Hospital, Faculty of Medicine, Cairo UniversityManar H Mohamed, Study director, Kasr Al-Ainy Hospital, Faculty of Medicine, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06408597
- Sponsor's protocol ID
- MVTKIPRARPC
- Status last verified
- Oct 2026
- First submitted
- 7 May 2024
- Last updated
- 20 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No