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Enhancing Renal Graft Function During Donor Anesthesia

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ClinicalTrials.gov Identifier: NCT03778944
Recruitment Status : Recruiting
First Posted : December 18, 2018
Last Update Posted : July 23, 2019
Sponsor:
Information provided by (Responsible Party):
Nazmy Edward Seif, Cairo University

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
Renal Failure Chronic Transplant;Failure,Kidney Anesthesia Procedure: Mannitol infusion Procedure: Dopamine infusion Procedure: Adequate hydration Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated 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]
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 : December 20, 2018
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Post-operative creatinine clearance [ Time Frame: 7 days ]
    Post-operative creatinine clearance level of the transplanted kidney graft is measured in ml/min



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • severe cardiac or hepatic dysfunction
  • coagulopathy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03778944


Contacts
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Contact: Nazmy E Seif, MD 01227400808 ext +2 drnazmyseif@yahoo.com
Contact: Ahmed M Elbadawy, MD 01064249076 ext +2 elbadawyahmed89@yahoo.com

Locations
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Egypt
Kasr Al-Ainy Hospital, Cairo University Recruiting
Cairo, Egypt
Contact: Nazmy E Seif, MD    01227400808 ext +2    drnazmyseif@yahoo.com   
Contact: Ahmed M Elbadawy, MD    01064249076 ext +2    elbadawyahmed89@yahoo.com   
Sponsors and Collaborators
Nazmy Edward Seif
Investigators
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Study Chair: Nazmy E Seif, MD Kasr Al-Ainy Hospital, Cairo University
Study Director: Ahmed M Elbadawy, MD Kasr Al-Ainy Hospital, Cairo University

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Responsible Party: Nazmy Edward Seif, Clinical Professor, Cairo University
ClinicalTrials.gov Identifier: NCT03778944     History of Changes
Other Study ID Numbers: RGFEDDA
First Posted: December 18, 2018    Key Record Dates
Last Update Posted: July 23, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nazmy Edward Seif, Cairo University:
Mannitol
Dopamine
Perfusion
Renal graft donor
Anesthesia
Additional relevant MeSH terms:
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Renal Insufficiency
Kidney Failure, Chronic
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Dopamine
Mannitol
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Cardiotonic Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Protective Agents
Diuretics, Osmotic
Diuretics
Natriuretic Agents