Enhancing Renal Graft Function During Donor Anesthesia

NCT03778944 | Recruiting DMC

• 1 other identifier: RGFEDDA
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Renal Failure Chronic; Transplant;Failure,Kidney; Anesthesia

Keywords

Mannitol; Dopamine; Perfusion; Renal graft donor; Anesthesia

Outcome Measures

Primary Outcomes (1)

• Post-operative creatinine clearance

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

  7 days

Study Arms (3)

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

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

Dopamine infusion PROCEDURE

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.

D group

Adequate hydration PROCEDURE

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.

C group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• severe cardiac or hepatic dysfunction
• coagulopathy

Sponsors & Collaborators

• Nazmy Edward Seif: lead

Study Sites (1)

Kasr Al-Ainy Hospital, Cairo University

Cairo, Egypt

RECRUITING

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Nazmy E Seif, MD

  Kasr Al-Ainy Hospital, Cairo University

  STUDY CHAIR

• Ahmed M Elbadawy, MD

  Kasr Al-Ainy Hospital, Cairo University

  STUDY DIRECTOR

Central Study Contacts

Nazmy E Seif, MD

CONTACT

01227400808; drnazmyseif@yahoo.com

Ahmed M Elbadawy, MD

CONTACT

01064249076; elbadawyahmed89@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Professor

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

Study Record Dates

• First Submitted: December 14, 2018
• First Posted: December 19, 2018
• Study Start: December 20, 2018
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 12, 2026

Record last verified: 2026-01

Locations

EG (1)