The Effect of Norepinephrine Versus Dopamine in Renal Transplant Recipients on Postoperative Graft Function

October 18, 2017 updated by: Ahmed Abdel Kader Ahmed Mohammed Elkadi, Assiut University
Renal transplantation is now recognized as a treatment of choice for patients with chronic renal failure with end-stage renal disease. Renal transplantations are associated with better quality of life, better cost/benefit ratio, and possibly longer survival. Significant changes in blood pressure are common throughout the surgical procedure for kidney transplantation. All efforts are made to maintain an appropriate level of blood pressure by using an adequate intravascular volume and vasopressor administration. All efforts are made to maintain an appropriate level of blood pressure by using an adequate intravascular volume and vasopressor administration. All efforts are made to maintain an appropriate level of blood pressure by using an adequate intravascular volume and vasopressor administration. All efforts are made to maintain an appropriate level of blood pressure by using an adequate intravascular volume and vasopressor administration.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

44

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Assiut, Egypt, 71515
        • Recruiting
        • Assiut university hospital
        • Contact:
          • Ahmed Elkadi
          • Phone Number: 01007485190

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 66 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients scheduled for a living donor kidney transplantation

Exclusion Criteria:

  • Patients (less than 18 years old)
  • Patients' refusal of consenting for enrolment in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Norepinephrine
Drug: Norepinephrine
Norepinephrine infusion will be used at a starting dose of 0.05μg/kg/min. Dose range: 0.05 -0.15 μg/kg/min. Infusion will be started with arterial decamping and continues till 24 hours postoperative
Active Comparator: Dopamine
Drug: Dopamine
Dopamine infusion will be used at a starting dose of 5μg/kg/min. Dose range: 5 -15 μg/kg/min. Infusion will be started with arterial decamping and continues till 24 hours postoperative

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
serum creatinine
Time Frame: four hours postoperatively
postoperative
four hours postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
blood urea
Time Frame: four hours postoperatively
postoperative
four hours postoperatively
urine output
Time Frame: over 24 hours
postoperative
over 24 hours
renal artery diameter
Time Frame: four hours postoperatively
Measured postoperative through renal artery Doppler
four hours postoperatively
renal artery blood flow
Time Frame: four hours postoperatively
Measured postoperative through renal artery Doppler
four hours postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

November 1, 2017

Primary Completion (Anticipated)

January 1, 2019

Study Completion (Anticipated)

November 1, 2019

Study Registration Dates

First Submitted

March 24, 2017

First Submitted That Met QC Criteria

April 10, 2017

First Posted (Actual)

April 11, 2017

Study Record Updates

Last Update Posted (Actual)

October 20, 2017

Last Update Submitted That Met QC Criteria

October 18, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NorepivsDopamine

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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