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

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

Sponsors

Lead sponsor: Guangdong Provincial People's Hospital

Collaborator: Peking University First Hospital
Chinese PLA General Hospital
Fudan University

Source 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 )

Overall Status Unknown status
Start Date July 2014
Completion Date July 2017
Primary Completion Date March 2016
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Contrast-Induced Nephropathy 72 hours
Contrast Induced Acute Kidney Injury 24 hours
Secondary Outcome
Measure Time Frame
contrast-induced acute kidney injury 48 hours
Composite contrast-induced acute kidney injury 48 hours
Persistent renal damage 3 months
Alteration of renal function 72 hours
Severe adverse renal events 1 year
Major adverse cardiovascular events 1 year
Enrollment 560
Condition
Intervention

Intervention type: Drug

Intervention name: Receiving hydration with a 1 mL/kg bolus of intravenous isotonic saline (0.9% sodium chloride)

Description: 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.

Arm group label: Guideline Hydration

Other name: Guideline Hydration

Intervention type: Drug

Intervention name: 3 mL/kg.hour bolus of intravenous isotonic saline (0.9% sodium chloride)

Description: 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.

Arm group label: Adequate Hydration

Other name: Adequate Hydration

Eligibility

Criteria:

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。

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Overall Official
Overall Contact

Last name: Jiyan Chen, MD

Phone: 86-20-83827812

Phone ext: 10528

Email: [email protected]

Location
facility status contact investigator Guangdong General Hospital Yong Liu, MD 86-20-83827812 10528 [email protected] Yuanhui Liu, MD Sub-Investigator Hualong Li, MD Sub-Investigator
Location Countries

China

Verification Date

August 2015

Responsible Party

Responsible party type: Principal Investigator

Investigator affiliation: Guangdong Provincial People's Hospital

Investigator full name: Jiyan Chen

Investigator title: MD

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: Guideline Hydration

Arm group type: Active Comparator

Description: 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.

Arm group label: Adequate Hydration

Arm group type: Active Comparator

Description: 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.

Acronym ATTEMPT
Study Design Info

Allocation: Randomized

Intervention model: Single Group Assignment

Primary purpose: Prevention

Masking: None (Open Label)

Source: ClinicalTrials.gov