Efficacy of Dexmedetomidine in Preventing Contrast Induced Nephropathy

NCT ID: NCT02137863

Last Updated: 2014-05-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2012-07-31

Brief Summary

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The aim of this study was to evaluate the effects of dexmedetomidine on renal function, hormonal and hemodynamic parameters in contrast media induced diabetic patients.

Detailed Description

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Contrast nephropathy may occur after using intravenous contrast media and may result in acute renal failure. Contrast nephropathy usually reversible but in some cases it can be permanent. This situation increase the time of hospitalization and mortality of the patients. Although the only proved prevention from contrast nephropathy method is hydration, infusion of dexmedetomidine may keep the renal functions.

Conditions

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Radiographic Contrast Agent Nephropathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Control

Before the angiography 0.9 % sodium chloride 3 ml/kg/h administered for 12 hours.

During the angiography and 12 hours after angiography 1 ml/kg/h 0.9 % sodium chloride administered.

100 ml/10min 0.9 % NaCl administered intravenously just before the angiography.

1 ml/kg/h 0.9 % sodium chloride administered intravenously during the procedure and was continued 1 hour after the angiography.

Group Type PLACEBO_COMPARATOR

0.9 % NaCl

Intervention Type DRUG

During 12 hours before the procedure 3 ml/kg/h 0.9 % NaCl infusion and 1 ml/kg/h during the angioplasty and 12 hours after the procedure.

0.9 % NaCl

Intervention Type DRUG

100 ml/10min infusion just before the angiography

1 ml/kg/h infusion during the angiography and was continued 12 hours after the procedure

Dexmedetomidine

Before the angiography 0.9 % sodium chloride 3 ml/kg/h administered for 12 hours.

During the angiography and 12 hours after angiography 1 ml/kg/h 0.9 % sodium chloride administered.

Dexmedetomidine was diluted as 1 μg/ml. 1 μg/kg/10min dexmedetomidine administered intravenously just before the angiography.

1 μg/kg/h dexmedetomidine administered intravenously during the procedure and was continued 1 hour after the angiography.

Group Type ACTIVE_COMPARATOR

Dexmedetomidine

Intervention Type DRUG

Intravenously 1μg/kg/10min administered just before the procedure.

1 μg/kg/h administered during the angiography and was continued 1 hour after the angiography.

0.9 % NaCl

Intervention Type DRUG

During 12 hours before the procedure 3 ml/kg/h 0.9 % NaCl infusion and 1 ml/kg/h during the angioplasty and 12 hours after the procedure.

Interventions

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Dexmedetomidine

Intravenously 1μg/kg/10min administered just before the procedure.

1 μg/kg/h administered during the angiography and was continued 1 hour after the angiography.

Intervention Type DRUG

0.9 % NaCl

During 12 hours before the procedure 3 ml/kg/h 0.9 % NaCl infusion and 1 ml/kg/h during the angioplasty and 12 hours after the procedure.

Intervention Type DRUG

0.9 % NaCl

100 ml/10min infusion just before the angiography

1 ml/kg/h infusion during the angiography and was continued 12 hours after the procedure

Intervention Type DRUG

Other Intervention Names

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Precedex Normal Saline Normal Saline

Eligibility Criteria

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Inclusion Criteria

* Scheduled for percutaneous coronary angiography
* \> 18 yo
* Diabetic patients
* Creatinin value \< 3 mg/dl

Exclusion Criteria

* Contrast agent hypersensitivity
* Pregnant patients
* Creatinin value ≥3mg/dl
* patients have acute renal failure
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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TC Erciyes University

OTHER

Sponsor Role lead

Responsible Party

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Aynur Akın

Prof Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Aynur Akın, Prof

Role: STUDY_CHAIR

TC Erciyes University

Other Identifiers

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2011/345

Identifier Type: -

Identifier Source: org_study_id

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