Ignite Creation Date:
2024-05-11 @ 8:30 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06408597
Status:
RECRUITING
Last Update Posted:
2024-05-14
First Post:
2024-05-07
Brief Title:
Mannitol Versus Nitroglycerin for Kidney Injury Prevention in Robotic-assisted Radical Prostatectomy or Cystectomy
Sponsor:
Nazmy Edward Seif
Organization:
Cairo University
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 hemodynamicfunction 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 hemodynamicfunction alterations during pneumoperitoneum
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 hemodynamicfunction 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 hemodynamicfunction alterations during pneumoperitoneum
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None