Comparing Human Albumin Versus Hydroxyethylstarch in Renal Transplant Recipients

Overview

In this study we try to review the possible effects when using modern hydroxyethylstarch solutions 6 % versus albumin 5% during living donor renal transplantation.

Full Title of Study: “Plasma Volume Expansion for Optimum Renal Transplant Surgery: Albumin Versus Starch”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Supportive Care
    • Masking: Single (Participant)
  • Study Primary Completion Date: February 1, 2019

Interventions

  • Other: Albumin resuscitation
    • Albumin 5% is used as the intra-operative colloid
  • Other: Hydroxyethylstarch resuscitation
    • Hydroxyethyl starch 6% is used as the intra-operative colloid
  • Drug: Albumin 5%
    • Infusion of Albumin 5% intra-operatively
  • Drug: Hydroxyethylstarch 6%
    • Infusion of Hydroxyethylstarch 6% intra-operatively

Arms, Groups and Cohorts

  • Active Comparator: Albumin group
    • Albumin resuscitation Albumin 5%
  • Experimental: Hydroxyethylstarch group
    • Hydroxyethylstarch resuscitation Hydroxyethylstarch 6%

Clinical Trial Outcome Measures

Primary Measures

  • Occurrence of complications
    • Time Frame: 7 days
    • Increased creatinine and/or need for dialysis

Participating in This Clinical Trial

Inclusion Criteria

  • end stage renal disease, for living donor renal transplantation Exclusion Criteria:

  • severe cardiac or hepatic dysfunction, re-transplantation, coagulopathy

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 60 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Cairo University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Ahmed Kareem, Principal Investigator – Cairo University
  • Overall Official(s)
    • Ahmed Kareem, Study Director, Kasr Al-Ainy Hospiral, Cairo University

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