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

August 20, 2015 updated by: Jiyan Chen, Guangdong Provincial People's Hospital

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
560

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 501080
        • Recruiting
        • Guangdong General Hospital
        • Contact:
        • Sub-Investigator:
          • Yuanhui Liu, MD
        • Sub-Investigator:
          • Hualong Li, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Guideline Hydration
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: 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.
Other Names:
  • Guideline Hydration
Active Comparator: Adequate Hydration
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.
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.
Other Names:
  • Adequate Hydration

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Contrast-Induced Nephropathy
Time Frame: 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
72 hours
Contrast Induced Acute Kidney Injury
Time Frame: 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.
24 hours

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
contrast-induced acute kidney injury
Time Frame: 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
48 hours
Composite contrast-induced acute kidney injury
Time Frame: 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
48 hours
Persistent renal damage
Time Frame: 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
3 months
Alteration of renal function
Time Frame: 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
72 hours
Severe adverse renal events
Time Frame: 1 year
Including contrast-induced nephropathy requiring renal replacement therapy and death caused by contrast-induced nephropathy
1 year
Major adverse cardiovascular events
Time Frame: 1 year
Major adverse cardiovascular events included death, re- current myocardial infarction, repeated urgent revascularization
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Guangdong Provincial People's Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Peking University First Hospital
Fudan University
Chinese PLA General Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jiyan Chen, MD, Guangdong Cardiovascular Institute,Guangdong General Hospital
  • Study Director: Yong Liu, MD, Guangdong Cardiovascular Institute,Guangdong General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2014

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2016

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 16, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 19, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 20, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 21, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 20, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CSC20140222

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