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

• ClinicalTrials.gov Identifier: NCT01948336
• Recruitment Status: Completed
• First Posted: September 23, 2013
• Last Update Posted: September 23, 2013
• Sponsor: TC Erciyes University
• Information provided by (Responsible Party): Adnan Bayram, TC Erciyes University

Tracking Information

• First Submitted Date: September 14, 2013
• First Posted Date: September 23, 2013
• Last Update Posted Date: September 23, 2013
• Study Start Date: April 2012
• Actual Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 18, 2013)

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.

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: September 18, 2013)

• 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).
• 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).
• 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).

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: The Effects of Dexmedetomidine on Early Stage Renal Functions in Pediatric Patients
• 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
• Brief Summary: The aim of this study is to evaluate the effect of dexmedetomidine infusion on early stage renal function.

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
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Prevention

Condition

• Renal Function Disorder
• Hemodynamic Instability

Intervention

• 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 Name: 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 Name: Ketalar
• Drug: Propofol
  propofol was bolused 1 mg kg-1 and 50 µg kg-1 min-1 propofol (IV) infusion during the procedure.
  Other Name: Pofol

Study Arms

• 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.
  Interventions:

  • Drug: Ketamine
  • Drug: Propofol
• 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.
  Interventions:

  • Drug: Dexmedetomidine
  • Drug: Ketamine
  • Drug: Propofol

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: September 18, 2013): 60
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: August 2013
• Actual Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 6 Months to 72 Months (Child)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT01948336
• Other Study ID Numbers: 2011-200
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Adnan Bayram, TC Erciyes University
• Original Responsible Party: Same as current
• Current Study Sponsor: TC Erciyes University
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

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

• PRS Account: TC Erciyes University
• Verification Date: September 2013