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

Sponsor
Assiut University (Other)
Overall Status
Unknown status
CT.gov ID
NCT03107858
Collaborator
(none)
44
Enrollment
1
Location
2
Arms
24
Anticipated Duration (Months)
1.8
Patients Per Site Per Month

Study Details

Study Description

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
Phase 2/Phase 3

Study Design

Study Type:
Interventional
Anticipated 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
Anticipated Study Start Date :
Nov 1, 2017
Anticipated Primary Completion Date :
Jan 1, 2019
Anticipated Study Completion Date :
Nov 1, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. serum creatinine [four hours postoperatively]

    postoperative

Secondary Outcome Measures

  1. blood urea [four hours postoperatively]

    postoperative

  2. urine output [over 24 hours]

    postoperative

  3. renal artery diameter [four hours postoperatively]

    Measured postoperative through renal artery Doppler

  4. renal artery blood flow [four hours postoperatively]

    Measured postoperative through renal artery Doppler

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Assiut University Hospital Assiut Egypt 71515

Sponsors and Collaborators

  • Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ahmed Abdel Kader Ahmed Mohammed Elkadi, Specialist, Assiut University
ClinicalTrials.gov Identifier:
NCT03107858
Other Study ID Numbers:
  • NorepivsDopamine
First Posted:
Apr 11, 2017
Last Update Posted:
Oct 20, 2017
Last Verified:
Oct 1, 2017
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
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:
Dopamine
Norepinephrine

Study Results

No Results Posted as of Oct 20, 2017