- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03107858
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 Contact
- Name: Ahmed Elkadi, MBBC
- Phone Number: +201007485190
- Email: ahmedkader333@gmail.com
Study Locations
-
-
-
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
16 years to 68 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
|
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
|
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
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
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Protective Agents
- Adrenergic alpha-Agonists
- Adrenergic Agonists
- Cardiotonic Agents
- Dopamine Agents
- Sympathomimetics
- Vasoconstrictor Agents
- Norepinephrine
- Dopamine
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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