NCT Number: NCT01948336
The aim of this study is to evaluate the effect of dexmedetomidine infusion on early stage renal function.
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Notify Me6 month–72 month
All sexes
Interventional
Phase 4
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
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
propofol was bolused 1 mg kg-1 and 50 µg kg-1 min-1 propofol (IV) infusion during the procedure.
Other names: Pofol
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.
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).
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).
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).
TC Erciyes University
Other
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
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