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

Sponsor

TC Erciyes University (Other)

Overall Status

Completed

CT.gov ID

NCT01948336

Collaborator

(none)

Enrollment

Arms

Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Renal Function Disorder Hemodynamic Instability	Drug: Dexmedetomidine Drug: Ketamine Drug: Propofol	Phase 4

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 Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Apr 1, 2012

Actual Primary Completion Date :

Apr 1, 2013

Actual Study Completion Date :

Aug 1, 2013

Arms and Interventions

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: 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 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

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: 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

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

Outcome Measures

Primary Outcome Measures

Renal Functions, [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.

Secondary Outcome Measures

Blood Pressure [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).
Heart rate [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).
peripheral oxygen saturation [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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Months to 72 Months

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

TC Erciyes University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Adnan Bayram, Assisstant Professor, TC Erciyes University

ClinicalTrials.gov Identifier:

NCT01948336

Other Study ID Numbers:

2011-200

First Posted:

Sep 23, 2013

Last Update Posted:

Sep 23, 2013

Last Verified:

Sep 1, 2013

Keywords provided by Adnan Bayram, Assisstant Professor, TC Erciyes University

Contrast-induced nephropathy, Dexmedetomidine, Endothelin-1

Additional relevant MeSH terms:

Dexmedetomidine

Ketamine

Propofol

Study Results

No Results Posted as of Sep 23, 2013