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Completed

NCT Number: NCT02137863

Efficacy of Dexmedetomidine in Preventing Contrast Induced Nephropathy

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.

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Key information

Conditions

Radiographic Contrast Agent Nephropathy Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexmedetomidine

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.

Other names: Precedex

0.9 % NaCl

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.

Other names: Normal Saline

Primary outcomes

  1. Changes in glomerular renal function after percutaneous coronary angiography as measured by neutrophil gelatinase-associated lipocalin, cystatin c, blood urea nitrogen, creatinin

    Time frame: 1 day (from start of angioplasty till discharge from the hospital)

Secondary outcomes

  1. blood pressure

    Time frame: 1 day (from start of angiography till discharge from the hospital)

  2. Heart rate

    Time frame: 1 day (from start of angiography till discharge from the hospital)

  3. Blood electrolyte levels ( sodium, potassium, chloride)

    Time frame: before the angiography and just before the discharge from hospital

  4. complete blood count

    Time frame: before the angiography and just before the discharge from hospital

Sponsors and collaborators

Lead sponsor

TC Erciyes University

Other

Registry information

Official study title

Phase 4 Study of Dexmedetomidine Effects on Preventing Contrast Induced Nephropathy

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
May 14, 2014
Registry last updated
May 14, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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