ClinicalTrials.gg
Active, not recruitingNCT06408597Updated Oct 20, 2026

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

An interventional study of Nitroglycerin Infusion and Mannitol Infusion in Prostate Cancer, Bladder Cancer and Surgery, sponsored by Nazmy Edward Seif. Active, not recruiting at 1 site in Egypt. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-10-20.

Sponsored by Nazmy Edward Seif · Not applicable, Interventional, and Supportive care

Updated Oct 20, 2026Primary completion movedStudy completion movedGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 25 studies in Prostatic Neoplasms with a site in Egypt — 7 open to participants now, 9 under way, none of them phase 3. Prostatic Neoplasms · Egypt.

Planned enrollment
5th of 18
90 · median 80
Started
2024
with 3 others
No phase
10 of 25
4 open now
Registered
17th of 25
by date
Lead sponsor
3 of 25
Nazmy Edward Seif

Among the 25 studies in Prostatic Neoplasms with a site in Egypt, this one is the 5th largest by planned enrollment of the 18 interventional ones that give a count, is one of 4 that started in 2024, is one of 10 with no phase, and was the 17th registered.

Prostatic Neoplasms

7,046 studies on the registry are indexed under Prostatic Neoplasms; 1,580 are open to participants now.

Browse Prostatic Neoplasms studies →

Open to participants now

7 of the 25 studies in Prostatic Neoplasms with a site in Egypt are open now. Recruiting first, the newest first:

2 more — sign in →

All 7 open studies →

A study can be open while its sites in Egypt have not opened yet or have stopped. Only those recruiting at a site in Egypt →

Who these studies take

Of the 1,228 Prostatic Neoplasms studies recruiting now, 928 (76%) set no upper age limit and 76 (6%) stop at 75 or younger; 67 take children under 18; 82 take healthy volunteers.

This study: 18 Years to 70 Years · all sexes · no healthy volunteers.

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02

Study 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.

03

Conditions studied

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

Keywords

  • Radical Prostatectomy
  • Radical Cystectomy
  • Robotic
  • Anesthesia
  • Mannitol
  • Nitroglycerin
04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • > 40
  • Previous renal surgery
  • Moderate ( 30 - 59 mg/dl) \& severe (GFR 15 - 29 mg/dl) renal impairment
  • Decompensated cardiac disease: (NYHA) class 3 or 4
  • Allergy to mannitol or nitroglycerin
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
90 participants (estimated)

Study arms

  • Active comparator
    Control group

    Standard Fluid Therapy group

    Procedure: Fluid Regimen

  • Experimental
    Nitroglycerin group

    Nitroglycerin Infusion group

    Procedure: Nitroglycerin Infusion · Procedure: Fluid Regimen

  • Experimental
    Mannitol group

    Mannitol Infusion group

    Procedure: Mannitol Infusion · Procedure: Fluid Regimen

Interventions

  • ProcedureNitroglycerin 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.

  • ProcedureMannitol 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.

  • ProcedureFluid 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.

06

What researchers measure

Primary outcomes

  1. Cystatin C level

    Serum Cystatin C value in mg/l

    Time frame: 24 hours

07

Study locations

1 site
08

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started May 2024 (actual). Primary completion is estimated for Nov 2026, 30 months after the start.

Of 1,098 non-industry interventional studies with no phase under Prostatic Neoplasms, half reached primary completion within 43 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 86. This study's planned 30 months is below that.

Counting every sponsor, half of 1,155 studies reached it within 43 months; a quarter within 22 and three quarters within 84.

Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 20, 2026: primary completion May 2026 → Nov 2026 and completion May 2026 → Nov 2026.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
May 7, 2024
First posted
May 10, 2024
StartActual
May 12, 2024
Primary completionEst.
Nov 2026was May 2026
CompletionEst.
Nov 2026was May 2026
Last update
Oct 20, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Primary completion
May 2026→Nov 2026
Oct 20, 2026
Study completion
May 2026→Nov 2026
Oct 20, 2026
Show all 1 update
  1. Oct 20, 2026
    Primary completion May 2026→Nov 2026
    Study completion May 2026→Nov 2026
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT06408597
Lead sponsor
Nazmy Edward Seif
Responsible party
Nazmy Edward Seif (Clinical Professor, Cairo University) — Sponsor-investigator
First posted
May 10, 2024
Start date
May 12, 2024
Primary completion
Nov 2026 (estimated)
Completion
Nov 2026 (estimated)
Last update
Oct 20, 2026

Study contacts

Ashgan R Ali, MD
study chair · Kasr Al-Ainy Hospital, Faculty of Medicine, Cairo University
Nazmy S Mikhael, MD
principal investigator · Kasr Al-Ainy Hospital, Faculty of Medicine, Cairo University
Manar H Mohamed
study director · Kasr Al-Ainy Hospital, Faculty of Medicine, Cairo University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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