Efficacy of Dexmedetomidine in Preventing Contrast Induced Nephropathy

Phase 4 Study of Dexmedetomidine Effects on Preventing Contrast Induced Nephropathy

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02137863

Enrollment

Registered

2014-05-14

Start date

2011-06-30

Completion date

2012-07-31

Last updated

2014-05-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Radiographic Contrast Agent Nephropathy

Keywords

Contrast induced nephropathy, Diabetes Mellitus, Dexmedetomidine

Brief summary

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

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.

Interventions

DRUGDexmedetomidine

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.

DRUG0.9 % 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Changes in glomerular renal function after percutaneous coronary angiography as measured by neutrophil gelatinase-associated lipocalin, cystatin c, blood urea nitrogen, creatinin	1 day (from start of angioplasty till discharge from the hospital)

Secondary

Measure	Time frame
blood pressure	1 day (from start of angiography till discharge from the hospital)
Heart rate	1 day (from start of angiography till discharge from the hospital)
Blood electrolyte levels ( sodium, potassium, chloride)	before the angiography and just before the discharge from hospital
complete blood count	before the angiography and just before the discharge from hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026