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

Not Applicable

• Conditions: ST Elevation Myocardial Infarction
• Interventions: Drug: Receiving hydration with a 1 mL/kg bolus of intravenous isotonic saline (0.9% sodium chloride); Drug: 3 mL/kg.hour bolus of intravenous isotonic saline (0.9% sodium chloride)

• Registration Number: NCT02067195
• Lead Sponsor: Guangdong Provincial People's Hospital

Brief 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 )

Study Timeline

• Study First Submitted: 2014-02-16
• Study First Submitted QC: 2014-02-19
• Study First Posted: 2014-02-20
• Study Start: 2014-07
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-20
• Last Update Posted: 2015-08-21
• Primary Completion: 2016-03
• Study Completion: 2017-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 560

Inclusion Criteria

• all consecutive patients with STEMI, age at least 18 years, who were candidates for primary PCI were considered for enrollment.

Exclusion Criteria

• contrast medium administration within the previous 14 days or follow 72 hours,
• end-stage renal failure or renal transplantation, and refuse PCI or dead during the procedure,
• heart failure of cardiac shock or New York Heart Association class IV,
• recent acute kidney injury defined as an absolute increase of 0.5 mg/dl in serum creatinine over baseline in the past 24h
• ,the presence of lactation, pregnancy,
• malignant tumour or life expectancy less than 1 year,
• allergy to contrast, peri-procedural receipt of metformin non-steroidalanti-inflammatory drugs in the past 48h and during the study period,
• planned renal catheterization or heart valvular surgery。

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Guideline Hydration	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.
Adequate Hydration	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.

Primary Outcome Measures

Name	Time	Method
Contrast Induced Acute Kidney Injury	24 hours	defined as a greater than 10% or an absolute increase of 0.3mg/dl in serum Cystatin C over baseline during the first 24 h post-procedure.
Contrast-Induced Nephropathy	72 hours	defined as a greater than 25% or an absolute increase of 0.5 mg/dl in serum creatinine over baseline during the first 48- 72 h post-procedure

Secondary Outcome Measures

Name	Time	Method
contrast-induced acute kidney injury	48 hours	defined as a greater than 50% or an absolute increase of 0.3 mg/dl in serum creatinine over baseline during the first 48h post-procedure
Alteration of renal function	72 hours	defined as the alteration of creatinine clearance and estimated glomerular filtration rate (GFR) by using Cystatin C over baseline during the first 48- 72 h post-procedure
Major adverse cardiovascular events	1 year	Major adverse cardiovascular events included death, re- current myocardial infarction, repeated urgent revascularization
Composite contrast-induced acute kidney injury	48 hours	Defined as an absolute increase of 0.3 mg/dl in serum creatinine over baseline during the first 48h post-procedure and as a greater than 10% in Cystatin C over baseline during the first 24h post-procedure
Persistent renal damage	3 months	Defined as a residual impairment of renal function indicated by a reduction of creatinine clearance more than 25% at 3 months in comparison with baseline
Severe adverse renal events	1 year	Including contrast-induced nephropathy requiring renal replacement therapy and death caused by contrast-induced nephropathy

Trial Locations

Locations (1)

Guangdong General Hospital; 🇨🇳 Guangzhou, Guangdong, China