Enhancing Renal Graft Function During Donor Anesthesia
Sponsor
Nazmy Edward Seif (Other)
Overall Status
Recruiting
CT.gov ID
NCT03778944
Collaborator
(none)
60
1
3
41.4
1.5
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention 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]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:
Single (Outcomes Assessor)
Primary Purpose:
Supportive Care
Official Title:
Renal Graft Functional Enhancement During Donor Anesthesia: A Comparative Study of 3 Modalities
Actual Study Start Date
:
Dec 20, 2018
Anticipated Primary Completion Date
:
Jun 1, 2022
Anticipated Study Completion Date
:
Jun 1, 2022
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: M group Mannitol infusion |
Procedure: Mannitol infusion
Infusion of Mannitol 20% at a dose of 0.5 mg/kg to the renal graft donor after induction of anesthesia over 15 minutes.
|
| Active Comparator: D group Dopamine infusion |
Procedure: Dopamine infusion
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.
|
| Active Comparator: C group Adequate hydration |
Procedure: Adequate hydration
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.
|
Outcome Measures
Primary Outcome Measures
- Post-operative creatinine clearance [7 days]
Post-operative creatinine clearance level of the transplanted kidney graft is measured in ml/min
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- end-stage renal disease, for living-donor kidney transplantation
Exclusion Criteria:
-
severe cardiac or hepatic dysfunction
-
coagulopathy
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Kasr Al-Ainy Hospital, Cairo University | Cairo | Egypt |
Sponsors and Collaborators
- Nazmy Edward Seif
Investigators
- Study Chair: Nazmy E Seif, MD, Kasr Al-Ainy Hospital, Cairo University
- Study Director: Ahmed M Elbadawy, MD, Kasr Al-Ainy Hospital, Cairo University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Nazmy Edward Seif,
Clinical Professor,
Cairo University
ClinicalTrials.gov Identifier:
NCT03778944
Other Study ID Numbers:
- RGFEDDA
First Posted:
Dec 19, 2018
Last Update Posted:
Mar 9, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Nazmy Edward Seif,
Clinical Professor,
Cairo University
Additional relevant MeSH terms: