The Effects of Dexmedetomidine on Early Stage Renal Functions in Pediatric Patients

September 18, 2013 updated by: Adnan Bayram, TC Erciyes University

Phase 4 THE EFFECTS OF DEXMEDETOMIDINE ON EARLY STAGE RENAL FUNCTIONS IN PEDIATRIC PATIENTS UNDERGOING CARDIAC ANGIOGRAPHY USING NON- IONIC CONTRAST MEDIA: A DOUBLE- BLIND, RANDOMIZED CLINICAL TRIAL

The aim of this study is to evaluate the effect of dexmedetomidine infusion on early stage renal function.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Background: Contrast-induced nephropathy is the third most common cause of acute renal failure in hospitalized patients in all age groups. In this study we aimed to investigate the effects of dexmedetomidine on early stage renal function in pediatric patients undergoing cardiac angiography.

Methods: 60 pediatric patients between 6 and 72 months of age undergoing cardiac angiography were included in the study. Patients were divided into two groups. The patients in both groups were administered 1mgkg-1 ketamine, 1mgkg-1 propofol as bolus and followed by 1 mgkg-1hour-1 ketamine and 50 µgkg-1min-1 propofol infusion. Additionally, a loading dose of 1 µgkg-1 dexmedetomidine given over 10 minutes followed by 0.5 µgkg-1hour-1 dexmedetomidine infusion to patients in group D. The patients were evaluated for NGAL, creatinine, renin, endothelin-1, TAS and TOS blood levels before the procedure and 6th and 24th hours after the procedure. pRIFLE criteria were used to define CIN and its incidence in the study.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 4

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

6 months to 6 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 6 and 72 months children
  • scheduled for cardiac angiography

Exclusion Criteria:

  • patients with renal failure or diabetes mellitus, patients who were on nephrotoxic and vasoactive drugs simultaneously, patients with decompensated congestive heart failure and patients who had been administered contrast media in the last two weeks

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: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Control
The patients in group C (control) (n=30) were bolused with 1 mg kg-1 ketamine (Ketalar®, Eczacibasi, Luleburgaz, Turkey) (IV) and 1 mg kg-1 propofol (Propofol 1% Fresenius, Fresenius Kabi Deutschland, Bad Homburg, Germany) (IV) followed by 1 mg kg-1 hour-1 ketamine (IV) and 50 µg kg-1 min-1 propofol (IV) infusion. Additionally a loading dose of 1 ml kg-1 D5 0.3% NaCl IV given over 10 minutes, followed by 0.5 ml kg-1 hour-1 IV D5 0.3% NaCl infusion were administered.
Drug: Ketamine
ketamine was bolused with 1 mg kg-1(IV) and followed by 1 mg kg-1 hour-1 ketamine IV infusion during the procedure.
Other Names:
  • Ketalar
Drug: Propofol
propofol was bolused 1 mg kg-1 and 50 µg kg-1 min-1 propofol (IV) infusion during the procedure.
Other Names:
  • Pofol
Active Comparator: Dexmedetomidine
The patients in group D (dexmedetomidine) (n=30) were bolused with 1mg kg-1 ketamine (IV), 1mg kg-1 propofol (IV) followed by 1 mg kg-1 hour-1 ketamine (IV) and 50 µg kg-1 min-1 propofol (IV) infusion. Additionally a loading dose of 1 µg kg-1 dexmedetomidine (Precedex Abbott Labs, North Chicago, IL) IV given over 10 minutes, followed by 0.5 µg kg-1 hour-1 IV dexmedetomidine infusion were administered. Dexmedetomidine was prepared as a 1 µg ml-1 solution using D5 0.3% NaCl solution.
Drug: Ketamine
ketamine was bolused with 1 mg kg-1(IV) and followed by 1 mg kg-1 hour-1 ketamine IV infusion during the procedure.
Other Names:
  • Ketalar
Drug: Propofol
propofol was bolused 1 mg kg-1 and 50 µg kg-1 min-1 propofol (IV) infusion during the procedure.
Other Names:
  • Pofol
Drug: Dexmedetomidine
a loading dose of 1 µg kg-1 dexmedetomidine (Precedex Abbott Labs, North Chicago, IL) IV given over 10 minutes, followed by 0.5 µg kg-1 hour-1 IV dexmedetomidine infusion were administered. Dexmedetomidine was prepared as a 1 µg ml-1 solution using D5 0.3% NaCl solution.
Other Names:
  • Precedex

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Renal Functions,
Time Frame: Baseline, changes from baseline at 6th and 24th hours after the cardiac angiography
The patients were evaluated for complete blood count and blood levels of creatinine (Cr), Neutrophil Gelatinase-Associated Lipocalin (NGAL), renin, endothelin-1, total antioxidant status (TAS) and total oxidant status (TOS) before the procedure and 6 and 24 hours after the procedure.
Baseline, changes from baseline at 6th and 24th hours after the cardiac angiography

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood Pressure
Time Frame: Up to 24 hours
After the patients were taken to the pediatric cardiac catheterization laboratory, mean arterial pressure (MAP), heart rate (HR), peripheral oxygen saturation (SpO2).
Up to 24 hours
Heart rate
Time Frame: Up to 24 hours
After the patients were taken to the pediatric cardiac catheterization laboratory, mean arterial pressure (MAP), heart rate (HR), peripheral oxygen saturation (SpO2).
Up to 24 hours
peripheral oxygen saturation
Time Frame: Up to 24 hours
After the patients were taken to the pediatric cardiac catheterization laboratory, mean arterial pressure (MAP), heart rate (HR), peripheral oxygen saturation (SpO2).
Up to 24 hours

Collaborators and Investigators

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

Sponsor

TC Erciyes University

Investigators

  • Study Chair: Adnan Bayram, Asst. Prof., TC Erciyes 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

April 1, 2012

Primary Completion (Actual)

April 1, 2013

Study Completion (Actual)

August 1, 2013

Study Registration Dates

First Submitted

September 14, 2013

First Submitted That Met QC Criteria

September 18, 2013

First Posted (Estimate)

September 23, 2013

Study Record Updates

Last Update Posted (Estimate)

September 23, 2013

Last Update Submitted That Met QC Criteria

September 18, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011-200

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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