Comparing Human Albumin Versus Hydroxyethylstarch in Renal Transplant Recipients

January 27, 2020 updated by: Ahmed Kareem, Cairo University

Plasma Volume Expansion for Optimum Renal Transplant Surgery: Albumin Versus Starch

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • Cairo University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • end stage renal disease, for living donor renal transplantation

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 15, 2017

Primary Completion (ACTUAL)

February 1, 2019

Study Completion (ACTUAL)

February 1, 2019

Study Registration Dates

First Submitted

October 6, 2017

First Submitted That Met QC Criteria

October 6, 2017

First Posted (ACTUAL)

October 11, 2017

Study Record Updates

Last Update Posted (ACTUAL)

January 28, 2020

Last Update Submitted That Met QC Criteria

January 27, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Albumin versus starch

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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