NCT02067195

Aggressive hydraTion in Patients With ST -Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention to prevenT Contrast-Induced Nephropathy

Aggressive Hydration in Patients With ST-Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention to Prevent Contrast-Induced Nephropathy, A Randomized, Controlled Trial REduction of riSk of Contrast-Induced Nephropathy followINg carDiac Catheterization 1

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 560 (estimated)
• Sponsor: Guangdong Provincial People's Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To compare the efficacy of 2 different hydration strategies, hydration according to clinical guideline and adequate hydration, on contrast-induced nephropathy in patients with STEMI undergoing primary PCI to investigate the possible beneficial role of periprocedural adequate hydration.

Detailed description

all consecutive patients with STEMI，age at least 18 years, who were candidates for primary PCI at our institution were considered for enrollment in the present study. Initial exclusion criteria were contrast medium administration within the previous 14 days, end-stage renal failure requiring dialysis, and refusal to give informed consent. Eligible patients were randomly assigned in a 1:1 ratio to receive preprocedure and postprocedure hydration (adequate hydration group), hydration according to clinical guideline (guideline hydration group，control group )

Conditions

• ST Elevation Myocardial Infarction

Interventions

Type	Name	Description
DRUG	Receiving hydration with a 1 mL/kg bolus of intravenous isotonic saline (0.9% sodium chloride)	No hydration for patients without chronic kidney disease(CrCl\<60ml/min),or Receiving hydration with a 1 mL/kg bolus of intravenous isotonic saline (0.9% sodium chloride) after diagnosis of chronic kidney disease until 24 hours after PCI. Hydration rate was reduced to 0.5 mL/kg per hour in patients with New York Heart Association class III or KillipⅡ/Ⅲ.
DRUG	3 mL/kg.hour bolus of intravenous isotonic saline (0.9% sodium chloride)	Receiving hydration with a 3 mL/kg.hour bolus of intravenous isotonic saline (0.9% sodium chloride) from randomization to the end of the procedure, the measurement of LVEDP was conducted after the procedure, a sliding-scale hydration was employed in the LVEDP-guided hydration arm that was based on LVEDP for 2 hours: 5 ml/kg/hr for LVEDP \<13 mmHg, 3 ml/kg/hr for LVEDP 13-18 mmHg, and \>1.5 ml/kg/hr for LVEDP \>18 mmHg, whereas,0.5 ml/kg/hr for LVEDP \>20 mmHg, continue hydration with a 1 mL/kg until 24 hours after procedure. Hydration rate was reduced to 0.5 mL/kg per hour in patients with New York Heart Association class III or KillipⅡ/Ⅲ.

Timeline

• Start date: 2014-07-01
• Primary completion: 2016-03-01
• Completion: 2017-07-01
• First posted: 2014-02-20
• Last updated: 2015-08-21

Locations

1 site across 1 country: China