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Enhancing Renal Graft Function During Donor Anesthesia

Primary Purpose

Renal Failure Chronic, Transplant;Failure,Kidney, Anesthesia

Status

Recruiting

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

Mannitol infusion

Dopamine infusion

Adequate hydration

About this trial

This is an interventional supportive care trial for Renal Failure Chronic focused on measuring Mannitol, Dopamine, Perfusion, Renal graft donor, Anesthesia

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

severe cardiac or hepatic dysfunction
coagulopathy

Sites / Locations

Kasr Al-Ainy Hospital, Cairo UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

M group

D group

C group

Arm Description

Mannitol infusion

Dopamine infusion

Adequate hydration

Outcomes

Primary Outcome Measures

Post-operative creatinine clearance

Post-operative creatinine clearance level of the transplanted kidney graft is measured in ml/min

Secondary Outcome Measures

Full Information

NCT ID

NCT03778944

First Posted

December 14, 2018

Last Updated

February 7, 2023

Sponsor

Nazmy Edward Seif

1. Study Identification

Unique Protocol Identification Number

NCT03778944

Brief Title

Enhancing Renal Graft Function During Donor Anesthesia

Official Title

Renal Graft Functional Enhancement During Donor Anesthesia: A Comparative Study of 3 Modalities

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Recruiting

Study Start Date

December 20, 2018 (Actual)

Primary Completion Date

July 2023 (Anticipated)

Study Completion Date

July 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Nazmy Edward Seif

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Renal Failure Chronic, Transplant;Failure,Kidney, Anesthesia

Keywords

Mannitol, Dopamine, Perfusion, Renal graft donor, Anesthesia

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Using computer & sealed envelope randomization, patients are assigned to receive either Mannitol [M group; n=20], Dopamine [D group; n=20] or adequate hydration [C group; n=20]

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

M group

Arm Type

Active Comparator

Arm Description

Mannitol infusion

Arm Title

D group

Arm Type

Active Comparator

Arm Description

Dopamine infusion

Arm Title

C group

Arm Type

Active Comparator

Arm Description

Adequate hydration

Intervention Type

Procedure

Intervention Name(s)

Mannitol infusion

Intervention Description

Infusion of Mannitol 20% at a dose of 0.5 mg/kg to the renal graft donor after induction of anesthesia over 15 minutes.

Intervention Type

Procedure

Intervention Name(s)

Dopamine infusion

Intervention Description

Infusion of Dopamine at a dose of 4 microg/kg/min to the renal graft donor after induction of anesthesia till ligation of the renal artery.

Intervention Type

Procedure

Intervention Name(s)

Adequate hydration

Intervention Description

Infusion of Ringer Acetate at a rate of 15 ml/kg/hr to the renal graft donor after induction of anesthesia till ligation of the renal artery.

Primary Outcome Measure Information:

Title

Post-operative creatinine clearance

Description

Post-operative creatinine clearance level of the transplanted kidney graft is measured in ml/min

Time Frame

7 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: end-stage renal disease, for living-donor kidney transplantation Exclusion Criteria: severe cardiac or hepatic dysfunction coagulopathy

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Nazmy E Seif, MD

Phone

01227400808

Ext

drnazmyseif@yahoo.com

First Name & Middle Initial & Last Name or Official Title & Degree

Ahmed M Elbadawy, MD

Phone

01064249076

Ext

elbadawyahmed89@yahoo.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Nazmy E Seif, MD

Organizational Affiliation

Kasr Al-Ainy Hospital, Cairo University

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Ahmed M Elbadawy, MD

Organizational Affiliation

Kasr Al-Ainy Hospital, Cairo University

Official's Role

Study Director

Facility Information:

Facility Name

Kasr Al-Ainy Hospital, Cairo University

City

Cairo

Country

Egypt

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Nazmy E Seif, MD

Phone

01227400808

Ext

drnazmyseif@yahoo.com

First Name & Middle Initial & Last Name & Degree

Ahmed M Elbadawy, MD

Phone

01064249076

Ext

elbadawyahmed89@yahoo.com

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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Enhancing Renal Graft Function During Donor Anesthesia

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