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Completed

NCT Number: NCT00998972

N-acetyl-cysteine (NAC) and Kidney Graft Function

The goal of this study is to evaluate the effect of N-acetyl-cysteine (NAC) administration in organ donors on the kidney graft function of recipients.

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Key information

About this study

Ischemia-reperfusion is a major contributing factor for delayed renal function after transplantation. It has been shown that the administration of an antioxidant, i.e. NAC, in patients with chronic renal insufficiency may prevent radio contrast-induced nephropathy. Due to its antioxidant effects, organ donor pretreatment with NAC has demonstrated to improve renal graft function in two experimental studies. Study objectives: to compare the incidence of delayed graft renal function between two groups of patients, i.e., those receiving the graft from organ donors pretreated with NAC and a group control. The primary endpoint was the number of delayed graft function defined as the requirement of at least one sequence of dialysis during the first seven days following transplantation. Secondary endpoints: evolution of creatininemia, azotemia at day 1, 7, 14 and ,30 after surgery; acute and delayed transplant rejection; intrahospital mortality.

Patients inclusion: all organ donors and recipients were eligible Exclusion criteria: for organ donors were preexistent chronic renal insufficiency and contra-indications for kidney procurement; for recipient were transplantation outside our hospital The donors were randomized in a single-blind fashion into two groups : the control group and the group receiving 600 mg IV of NAC 1 hour before and 600 mg IV 2 hours after cerebral arteriography required to diagnose brain death. Sample size has been calculated delayed graft function by 50% leading to include 118 recipients in each group.

Follow up: one year after transplantation. Study beginning in september 2006. Length of inclusion during 36 months.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • all recipient for kidney graft in our hospital

Exclusion criteria

  • transplantation out side our hospital
  • refusal from the patient

Treatment and study plan

N-acetylcysteine

Drug

600 mg intravenous before and 2 hours after cerebral arteriography

Other names: n-acetylcysteine administration

Primary outcomes

  1. Incidence of delayed graft function

    Time frame: 1 year

Secondary outcomes

  1. Evolution of creatininemia and azotemia during the first month after transplantation

    Time frame: 30 days

  2. Intrahospital mortality

    Time frame: 30 days

  3. Acute and delayed graft rejection

    Time frame: 30 days

Sponsors and collaborators

Lead sponsor

Institut d'Anesthesiologie des Alpes Maritimes

Other

Registry information

Official study title

Preventive Administration of N-acetyl-cysteine (NAC) in Organ Donor: Effects on Kidney Graft Function

Important dates

Study start
2006
Primary completion
2010
Study completion
2011
First posted
Oct 21, 2009
Registry last updated
Jul 12, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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