NCT03107858

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
44

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Nov 2017

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 24, 2017

Completed
18 days until next milestone

First Posted

Study publicly available on registry

April 11, 2017

Completed
7 months until next milestone

Study Start

First participant enrolled

November 1, 2017

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2019

Completed
Last Updated

October 20, 2017

Status Verified

October 1, 2017

Enrollment Period

1.2 years

First QC Date

March 24, 2017

Last Update Submit

October 18, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • serum creatinine

    postoperative

    four hours postoperatively

Secondary Outcomes (4)

  • blood urea

    four hours postoperatively

  • urine output

    over 24 hours

  • renal artery diameter

    four hours postoperatively

  • renal artery blood flow

    four hours postoperatively

Study Arms (2)

Norepinephrine

ACTIVE COMPARATOR
Drug: Norepinephrine

Dopamine

ACTIVE COMPARATOR
Drug: Dopamine

Interventions

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

Norepinephrine

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

Dopamine

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients scheduled for a living donor kidney transplantation

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut University Hospital

Asyut, 71515, Egypt

RECRUITING

MeSH Terms

Interventions

NorepinephrineDopamine

Intervention Hierarchy (Ancestors)

EthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesBiogenic MonoaminesBiogenic AminesCatecholaminesCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbons

Central Study Contacts

Ahmed Elkadi, MBBC

CONTACT

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Specialist

Study Record Dates

First Submitted

March 24, 2017

First Posted

April 11, 2017

Study Start

November 1, 2017

Primary Completion

January 1, 2019

Study Completion

November 1, 2019

Last Updated

October 20, 2017

Record last verified: 2017-10

Locations