Ignite Creation Date:
2024-05-05 @ 4:37 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00286403
Status:
WITHDRAWN
Last Update Posted:
2016-03-28
First Post:
2006-02-01
Brief Title:
Vasodilators and Anti-Oxidant Therapy in Early ATN
Sponsor:
Southeast Renal Research Institute
Organization:
Southeast Renal Research Institute
Study Overview
Official Title:
Combination Fenoldopam Mesylate and Intravenous MESNA 2-mercaptoethane Sulphonatein Early Acute Kidney Injury AKD A Randomized Double-Blind Placebo Controlled Clinical Trial
Status:
WITHDRAWN
Status Verified Date:
2016-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The study was terminated due to logistics at a local hospital
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Patients developing kidney failure after open heart surgery experience an abrupt decrease in blood flow to the kidney The investigators hypothesize that administration of fenoldopam mesylate a drug that increases blood flow to the kidney to patients early in the course of their disease could reduce progression to dialysis-dependent acute renal failure The investigators also hypothesize that restoring blood flow could induce additional injury to the kidney through the release of reactive oxygen species Therefore patients in this protocol will be randomized to receive a fenoldopam or the anti-oxidant MESNA The investigators hypothesize that combination treatment with Fenoldopam and MESNA will decrease the incidence of death or dialysis at 21 days in patients with early post-operative acute renal failure
Detailed Description:
Primary Hypotheses
Combination therapy with intravenous fenoldopam mesylate and MESNA will reduce the incidence of dialysis and all cause mortality at 21 days in patients with established acute tubular necrosis ATN
The combination of fenoldopam mesylate and Intravenous MESNA reduces the level of reactive oxygen species released following restoration of renal blood flow in patients with ischemic ATN
Specific Aims
1 To conduct a multicenter double blind trial comparing the efficacy of a 72-hour infusion of fenoldopam mesylate or combination of fenoldopam plus intravenous MESNA to reduce the incidence of dialysis or all-cause mortality at 21 days in patients with ischemic ATN
2 To determine the effects of fenoldopam mesylate alone or in combination with MESNA on reperfusion injury as evidenced by changes in the level of urinary 15-F2t-isoprostanes The rational is that failure of parenteral vasodilators to reduce the incidence of death or dialysis among patients with ATN may involve the extension of tubular injury through normalization of renal blood flow and subsequent reperfusion injury Moreover the generation of reactive oxidative species in areas of hypoxia could blunt impair regional blood flow in the kidney through inhibition of nitric oxide production
3 To serially measure the urinary content of ICAM-1 VCAM-1 KIM-1 P-selectin E-selectin MCP-1and Cyr-61 and determine the ability of specific markers to identify patients progressing to dialysis dependent ATN
The rational is that ICAM-1 is expressed by ischemic endothelium and facilitates neutrophile migration into areas of necrotic epithelium We will determine whether rising urinary ICAM-1 will identify patients with progressive dialysis-dependent ATN Specific aim 3 will also examine whether a reduction in dialysis or all cause mortality by fenoldopam mesylate correlates with reduced urinary expression of ICAM-1 or other cell adhesion molecules The serum plasma urine supernatant and urinary casts obtained from patients enrolled in this trial will be made available to other investigators involved in the study of early ATN
Combination therapy with intravenous fenoldopam mesylate and MESNA will reduce the incidence of dialysis and all cause mortality at 21 days in patients with established acute tubular necrosis ATN
The combination of fenoldopam mesylate and Intravenous MESNA reduces the level of reactive oxygen species released following restoration of renal blood flow in patients with ischemic ATN
Specific Aims
1 To conduct a multicenter double blind trial comparing the efficacy of a 72-hour infusion of fenoldopam mesylate or combination of fenoldopam plus intravenous MESNA to reduce the incidence of dialysis or all-cause mortality at 21 days in patients with ischemic ATN
2 To determine the effects of fenoldopam mesylate alone or in combination with MESNA on reperfusion injury as evidenced by changes in the level of urinary 15-F2t-isoprostanes The rational is that failure of parenteral vasodilators to reduce the incidence of death or dialysis among patients with ATN may involve the extension of tubular injury through normalization of renal blood flow and subsequent reperfusion injury Moreover the generation of reactive oxidative species in areas of hypoxia could blunt impair regional blood flow in the kidney through inhibition of nitric oxide production
3 To serially measure the urinary content of ICAM-1 VCAM-1 KIM-1 P-selectin E-selectin MCP-1and Cyr-61 and determine the ability of specific markers to identify patients progressing to dialysis dependent ATN
The rational is that ICAM-1 is expressed by ischemic endothelium and facilitates neutrophile migration into areas of necrotic epithelium We will determine whether rising urinary ICAM-1 will identify patients with progressive dialysis-dependent ATN Specific aim 3 will also examine whether a reduction in dialysis or all cause mortality by fenoldopam mesylate correlates with reduced urinary expression of ICAM-1 or other cell adhesion molecules The serum plasma urine supernatant and urinary casts obtained from patients enrolled in this trial will be made available to other investigators involved in the study of early ATN
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None