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

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

NCT ID: NCT06408597

Condition: Prostate Cancer
Bladder Cancer
Surgery
Renal Impairment
Renal Injury, Acute

Conditions: Official terms:
Renal Insufficiency
Acute Kidney Injury
Wounds and Injuries
Mannitol
Nitroglycerin

Conditions: Keywords:
Radical Prostatectomy
Radical Cystectomy
Robotic
Anesthesia
Mannitol
Nitroglycerin

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Supportive Care

Masking: Double (Participant, Outcomes Assessor)

Intervention:

Intervention type: Procedure
Intervention name: Nitroglycerin Infusion
Description: 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.
Arm group label: Nitroglycerin group

Intervention type: Procedure
Intervention name: Mannitol Infusion
Description: 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.
Arm group label: Mannitol group

Intervention type: Procedure
Intervention name: Fluid Regimen
Description: 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.
Arm group label: Control group
Arm group label: Mannitol group
Arm group label: Nitroglycerin group

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.

Criteria for eligibility:
Criteria:
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

Gender: All

Minimum age: 18 Years

Maximum age: 70 Years

Healthy volunteers: No

Locations:

Facility:
Name: Cairo University Hospitals

Address:
City: Cairo
Country: Egypt

Status: Recruiting

Contact:
Last name: Manar H Mohamed, MBBCH

Phone: 01210405856

Phone ext: +2
Email: manar95hamdy3@gmail.com

Contact backup:
Last name: Nazmy S Mikhael, MD

Phone: 01227400808

Phone ext: +2
Email: drnazmyseif@kasralainy.edu.eg

Start date: May 12, 2024

Completion date: November 2024

Lead sponsor:
Agency: Nazmy Edward Seif
Agency class: Other

Source: Cairo University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06408597