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

ST Elevation Myocardial Infarction Clinical Trial

— ATTEMPT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02067195
• Other study ID #: CSC20140222
• Status: Recruiting
• Phase: N/A
• First received: February 16, 2014
• Last updated: August 20, 2015
• Start date: July 2014
• Est. completion date: July 2017

Study information

• Verified date: August 2015
• Source: Guangdong General Hospital
• Contact: Jiyan Chen, MD
• Phone: 86-20-83827812
• Email: chenjiyandr[@]126.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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 )

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 560
• Est. completion date: July 2017
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction
• ST Elevation Myocardial Infarction

Intervention

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 Killip?/?.
• 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 Killip?/?.

Locations

Country	Name	City	State
China	Guangdong General Hospital	Guangzhou	Guangdong

Sponsors (4)

Lead Sponsor	Collaborator
Guangdong General Hospital	Chinese PLA General Hospital, Fudan University, Peking University First Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Contrast-Induced Nephropathy	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	72 hours	No
Primary	Contrast Induced Acute Kidney Injury	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.	24 hours	No
Secondary	contrast-induced acute kidney injury	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	48 hours	No
Secondary	Composite contrast-induced acute kidney injury	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	48 hours	No
Secondary	Persistent renal damage	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	3 months	No
Secondary	Alteration of renal function	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	72 hours	No
Secondary	Severe adverse renal events	Including contrast-induced nephropathy requiring renal replacement therapy and death caused by contrast-induced nephropathy	1 year	No
Secondary	Major adverse cardiovascular events	Major adverse cardiovascular events included death, re- current myocardial infarction, repeated urgent revascularization	1 year	No