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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03107858
Recruitment Status : Unknown
Verified October 2017 by Ahmed Abdel Kader Ahmed Mohammed Elkadi, Assiut University.
Recruitment status was:  Recruiting
First Posted : April 11, 2017
Last Update Posted : October 20, 2017
Sponsor:
Information provided by (Responsible Party):
Ahmed Abdel Kader Ahmed Mohammed Elkadi, Assiut University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Renal Transplant Drug: Norepinephrine Drug: Dopamine Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Effect of Norepinephrine Versus Dopamine in Renal Transplant Recipients on Postoperative Graft Function
Estimated Study Start Date : November 1, 2017
Estimated Primary Completion Date : January 1, 2019
Estimated Study Completion Date : November 1, 2019

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. serum creatinine [ Time Frame: four hours postoperatively ]
    postoperative


Secondary Outcome Measures :
  1. blood urea [ Time Frame: four hours postoperatively ]
    postoperative

  2. urine output [ Time Frame: over 24 hours ]
    postoperative

  3. renal artery diameter [ Time Frame: four hours postoperatively ]
    Measured postoperative through renal artery Doppler

  4. renal artery blood flow [ Time Frame: four hours postoperatively ]
    Measured postoperative through renal artery Doppler



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT03107858


Contacts
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Contact: Ahmed Elkadi, MBBC +201007485190 ahmedkader333@gmail.com

Locations
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Egypt
Assiut University Hospital Recruiting
Assiut, Egypt, 71515
Contact: Ahmed Elkadi    01007485190      
Sponsors and Collaborators
Assiut University
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Responsible Party: Ahmed Abdel Kader Ahmed Mohammed Elkadi, Specialist, Assiut University
ClinicalTrials.gov Identifier: NCT03107858    
Other Study ID Numbers: NorepivsDopamine
First Posted: April 11, 2017    Key Record Dates
Last Update Posted: October 20, 2017
Last Verified: October 2017
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
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Dopamine
Norepinephrine
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Vasoconstrictor Agents
Cardiotonic Agents
Dopamine Agents
Protective Agents