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Comparing Human Albumin Versus Hydroxyethylstarch in Renal Transplant Recipients

Sponsor
Cairo University (Other)
Overall Status
Completed
CT.gov ID
NCT03306914
Collaborator
(none)
120
Enrollment
1
Location
2
Arms
15.6
Actual Duration (Months)
7.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Other: Albumin resuscitation
  • Other: Hydroxyethylstarch resuscitation
  • Drug: Albumin 5%
  • Drug: Hydroxyethylstarch 6%
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
120 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Supportive Care
Official Title:
Plasma Volume Expansion for Optimum Renal Transplant Surgery: Albumin Versus Starch
Actual Study Start Date :
Oct 15, 2017
Actual Primary Completion Date :
Feb 1, 2019
Actual Study Completion Date :
Feb 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Albumin group

Albumin resuscitation Albumin 5%

Other: Albumin resuscitation
Albumin 5% is used as the intra-operative colloid

Drug: Albumin 5%
Infusion of Albumin 5% intra-operatively
Other Names:
  • Albumin

    		•
    Experimental: Hydroxyethylstarch group

    Hydroxyethylstarch resuscitation Hydroxyethylstarch 6%

    Other: Hydroxyethylstarch resuscitation
    Hydroxyethyl starch 6% is used as the intra-operative colloid

    Drug: Hydroxyethylstarch 6%
    Infusion of Hydroxyethylstarch 6% intra-operatively
    Other Names:
  • Tetraspan

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Occurrence of complications [7 days]

      Increased creatinine and/or need for dialysis

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • end stage renal disease, for living donor renal transplantation
    Exclusion Criteria:
    • severe cardiac or hepatic dysfunction, re-transplantation, coagulopathy

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Cairo University Cairo Egypt

    Sponsors and Collaborators

    • Cairo University

    Investigators

    • Study Director: Ahmed Kareem, Kasr Al-Ainy Hospiral, Cairo University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ahmed Kareem, Principal Investigator, Cairo University
    ClinicalTrials.gov Identifier:
    NCT03306914
    Other Study ID Numbers:
    • Albumin versus starch
    First Posted:
    Oct 11, 2017
    Last Update Posted:
    Jan 28, 2020
    Last Verified:
    Jan 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Hydroxyethyl Starch Derivatives

    Study Results

    No Results Posted as of Jan 28, 2020