Enhancing Renal Graft Function During Donor Anesthesia | NCT03778944

Studies
Enhancing Renal Graft Function During Donor Anesthesia

NCT03778944

Sponsor

Nazmy Edward Seif

Status

Recruiting

Last Update Posted

Jan 12, 2026Actual

Enrollment

60Estimated

Phase

Not Applicable

Conditions

Renal Failure Chronic
Transplant;Failure,Kidney
Anesthesia

Interventions

Mannitol infusion
Dopamine infusion
Adequate hydration

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 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 20, 2018Actual

Primary Completion Date

Dec 2026Estimated

Completion Date

Dec 2026Estimated

First Submitted Date

Dec 14, 2018

First Submission Date that Met QC Criteria

Dec 17, 2018

First Posted Date

Dec 19, 2018Actual

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 8, 2026

Last Update Posted Date

Jan 12, 2026Actual

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

Renal transplantation is now recognized as the treatment of choice for patients with end-stage renal disease. An optimum anesthetic regimen should enhance the function and perfusion of the transplanted kidney. The aim of this study is to assess & compare the effectiveness of 3 different modalities in this respect: Mannitol, Dopamine and adequate hydration.

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

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
M group	Active Comparator	Mannitol infusion	Procedure: Mannitol infusion
D group	Active Comparator	Dopamine infusion	Procedure: Dopamine infusion
C group	Active Comparator	Adequate hydration	Procedure: Adequate hydration

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Mannitol infusion	Procedure	Infusion of Mannitol 20% at a dose of 0.5 mg/kg to the renal graft donor after induction of anesthesia over 15 minutes.	M group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Post-operative creatinine clearance	Post-operative creatinine clearance level of the transplanted kidney graft is measured in ml/min	7 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

end-stage renal disease, for living-donor kidney transplantation

Exclusion Criteria:

severe cardiac or hepatic dysfunction
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

Name	Role	Phone	Extension	Email
Nazmy E Seif, MD	Contact	01227400808	+2	drnazmyseif@yahoo.com
Ahmed M Elbadawy, MD	Contact	01064249076	+2	elbadawyahmed89@yahoo.com

Overall Officials

Name	Affiliation	Role
Nazmy E Seif, MD	Kasr Al-Ainy Hospital, Cairo University	Study Chair
Ahmed M Elbadawy, MD	Kasr Al-Ainy Hospital, Cairo University	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kasr Al-Ainy Hospital, Cairo University	Recruiting	Cairo			Egypt

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D051436	Renal Insufficiency, Chronic

Ancestor Terms

ID	Term
D051437	Renal Insufficiency
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided