NCT03306914

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 6, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 11, 2017

Completed
4 days until next milestone

Study Start

First participant enrolled

October 15, 2017

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2019

Completed
Last Updated

January 28, 2020

Status Verified

January 1, 2020

Enrollment Period

1.3 years

First QC Date

October 6, 2017

Last Update Submit

January 27, 2020

Conditions

Anesthesia Morbidity

Outcome Measures

Primary Outcomes (1)

  • Occurrence of complications

    Increased creatinine and/or need for dialysis

    7 days

Study Arms (2)

Albumin group

ACTIVE COMPARATOR

Albumin resuscitation Albumin 5%

Other: Albumin resuscitationDrug: Albumin 5%

Hydroxyethylstarch group

EXPERIMENTAL

Hydroxyethylstarch resuscitation Hydroxyethylstarch 6%

Other: Hydroxyethylstarch resuscitationDrug: Hydroxyethylstarch 6%

Interventions

Albumin resuscitationOTHER

Albumin 5% is used as the intra-operative colloid

Albumin group
Hydroxyethylstarch resuscitationOTHER

Hydroxyethyl starch 6% is used as the intra-operative colloid

Hydroxyethylstarch group
Albumin 5%DRUG

Infusion of Albumin 5% intra-operatively

Also known as: Albumin
Albumin group
Hydroxyethylstarch 6%DRUG

Infusion of Hydroxyethylstarch 6% intra-operatively

Also known as: Tetraspan
Hydroxyethylstarch group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • end stage renal disease, for living donor renal transplantation

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University

Cairo, Egypt

Location

MeSH Terms

Interventions

zidovudine 5'-monophosphate-mannose-albumin conjugateAlbumins

Intervention Hierarchy (Ancestors)

ProteinsAmino Acids, Peptides, and Proteins

Study Officials

  • Ahmed Kareem

    Kasr Al-Ainy Hospiral, Cairo University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 6, 2017

First Posted

October 11, 2017

Study Start

October 15, 2017

Primary Completion

February 1, 2019

Study Completion

February 1, 2019

Last Updated

January 28, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)