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

NCT01948336 | Completed Phase 4

• 1 other identifier: 2011-200
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Renal Function Disorder; Hemodynamic Instability

Keywords

Contrast-induced nephropathy, Dexmedetomidine, Endothelin-1

Outcome Measures

Primary Outcomes (1)

• Renal Functions,

  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 Outcomes (3)

• Blood Pressure

  Up to 24 hours

• Heart rate

  Up to 24 hours

• peripheral oxygen saturation

  Up to 24 hours

Study Arms (2)

Control

PLACEBO COMPARATOR

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; Drug: Propofol

Dexmedetomidine

ACTIVE COMPARATOR

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; Drug: Ketamine; Drug: Propofol

Interventions

Dexmedetomidine DRUG

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.

Also known as: Precedex

Dexmedetomidine

Ketamine DRUG

ketamine was bolused with 1 mg kg-1(IV) and followed by 1 mg kg-1 hour-1 ketamine IV infusion during the procedure.

Also known as: Ketalar

Control; Dexmedetomidine

Propofol DRUG

propofol was bolused 1 mg kg-1 and 50 µg kg-1 min-1 propofol (IV) infusion during the procedure.

Also known as: Pofol

Control; Dexmedetomidine

Eligibility Criteria

• Age: 6 Months - 72 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• and 72 months children
• scheduled for cardiac angiography

You may not qualify if:

• 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

Sponsors & Collaborators

• TC Erciyes University: lead

MeSH Terms

Interventions

Dexmedetomidine; Ketamine; Propofol

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic

Study Officials

• Adnan Bayram, Asst. Prof.

  TC Erciyes University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assisstant Professor

Study Record Dates

• First Submitted: September 14, 2013
• First Posted: September 23, 2013
• Study Start: April 1, 2012
• Primary Completion: April 1, 2013
• Study Completion: August 1, 2013
• Last Updated: September 23, 2013

Record last verified: 2013-09