Comparing Human Albumin Versus Hydroxyethylstarch in Rena... | NCT03306914

Studies
Comparing Human Albumin Versus Hydroxyethylstarch in Renal Transplant Recipients

NCT03306914

Sponsor

Cairo University

Status

Completed

Last Update Posted

Jan 28, 2020Actual

Enrollment

120Actual

Phase

Not Applicable

Conditions

Anesthesia Morbidity

Interventions

Albumin resuscitation
Hydroxyethylstarch resuscitation
Albumin 5%
Hydroxyethylstarch 6%

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 15, 2017Actual

Primary Completion Date

Feb 1, 2019Actual

Completion Date

Feb 1, 2019Actual

First Submitted Date

Oct 6, 2017

First Submission Date that Met QC Criteria

Oct 6, 2017

First Posted Date

Oct 11, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 27, 2020

Last Update Posted Date

Jan 28, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

120Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Albumin group	Active Comparator	Albumin resuscitation Albumin 5%	Other: Albumin resuscitation Drug: Albumin 5%
Hydroxyethylstarch group	Experimental	Hydroxyethylstarch resuscitation Hydroxyethylstarch 6%	Other: Hydroxyethylstarch resuscitation Drug: Hydroxyethylstarch 6%

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Albumin resuscitation	Other	Albumin 5% is used as the intra-operative colloid	Albumin group

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

end stage renal disease, for living donor renal transplantation

Exclusion Criteria:

severe cardiac or hepatic dysfunction, re-transplantation, coagulopathy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ahmed Kareem	Kasr Al-Ainy Hospiral, Cairo University	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cairo University		Cairo			Egypt

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C067831	zidovudine 5'-monophosphate-mannose-albumin conjugate
D000418	Albumins

Ancestor Terms

ID	Term
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins

Browse Leaves

Not provided

Browse Branches

Not provided