search
Back to results

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

Primary Purpose

ST Elevation Myocardial Infarction

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Receiving hydration with a 1 mL/kg bolus of intravenous isotonic saline (0.9% sodium chloride)
3 mL/kg.hour bolus of intravenous isotonic saline (0.9% sodium chloride)
Sponsored by
Guangdong Provincial People's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for ST Elevation Myocardial Infarction focused on measuring acute myocardial infarction,contrast,coronary intervention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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。

Sites / Locations

  • Guangdong General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Guideline Hydration

Adequate Hydration

Arm 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.

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.

Outcomes

Primary Outcome Measures

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
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.

Secondary Outcome Measures

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
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
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
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
Severe adverse renal events
Including contrast-induced nephropathy requiring renal replacement therapy and death caused by contrast-induced nephropathy
Major adverse cardiovascular events
Major adverse cardiovascular events included death, re- current myocardial infarction, repeated urgent revascularization

Full Information

First Posted
February 16, 2014
Last Updated
August 20, 2015
Sponsor
Guangdong Provincial People's Hospital
Collaborators
Peking University First Hospital, Chinese PLA General Hospital, Fudan University
search

1. Study Identification

Unique Protocol Identification Number
NCT02067195
Brief Title
Aggressive hydraTion in Patients With ST -Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention to prevenT Contrast-Induced Nephropathy
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Unknown status
Study Start Date
July 2014 (undefined)
Primary Completion Date
March 2016 (Anticipated)
Study Completion Date
July 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Guangdong Provincial People's Hospital
Collaborators
Peking University First Hospital, Chinese PLA General Hospital, Fudan University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 )

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ST Elevation Myocardial Infarction
Keywords
acute myocardial infarction,contrast,coronary intervention

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
560 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Guideline Hydration
Arm Type
Active Comparator
Arm 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 Title
Adequate Hydration
Arm Type
Active Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Receiving hydration with a 1 mL/kg bolus of intravenous isotonic saline (0.9% sodium chloride)
Other Intervention Name(s)
Guideline Hydration
Intervention 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.
Intervention Type
Drug
Intervention Name(s)
3 mL/kg.hour bolus of intravenous isotonic saline (0.9% sodium chloride)
Other Intervention Name(s)
Adequate Hydration
Intervention 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.
Primary Outcome Measure Information:
Title
Contrast-Induced Nephropathy
Description
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
Time Frame
72 hours
Title
Contrast Induced Acute Kidney Injury
Description
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.
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
contrast-induced acute kidney injury
Description
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
Time Frame
48 hours
Title
Composite contrast-induced acute kidney injury
Description
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
Time Frame
48 hours
Title
Persistent renal damage
Description
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
Time Frame
3 months
Title
Alteration of renal function
Description
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
Time Frame
72 hours
Title
Severe adverse renal events
Description
Including contrast-induced nephropathy requiring renal replacement therapy and death caused by contrast-induced nephropathy
Time Frame
1 year
Title
Major adverse cardiovascular events
Description
Major adverse cardiovascular events included death, re- current myocardial infarction, repeated urgent revascularization
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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。
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jiyan Chen, MD
Phone
86-20-83827812
Ext
10528
Email
chenjiyandr@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jiyan Chen, MD
Organizational Affiliation
Guangdong Cardiovascular Institute,Guangdong General Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yong Liu, MD
Organizational Affiliation
Guangdong Cardiovascular Institute,Guangdong General Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Guangdong General Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
501080
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yong Liu, MD
Phone
86-20-83827812
Ext
10528
Email
liuyong2099@126.com
First Name & Middle Initial & Last Name & Degree
Yuanhui Liu, MD
First Name & Middle Initial & Last Name & Degree
Hualong Li, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
32580757
Citation
Guo W, Song F, Chen S, Zhang L, Sun G, Liu J, Chen J, Liu Y, Tan N; RESCIND group. The relationship between hyperuricemia and contrast-induced acute kidney injury undergoing primary percutaneous coronary intervention: secondary analysis protocol for the ATTEMPT RESCIND-1 study. Trials. 2020 Jun 24;21(1):567. doi: 10.1186/s13063-020-04505-w.
Results Reference
derived
PubMed Identifier
32395501
Citation
Liu J, Guo Z, Lei L, Sun G, He Y, Song F, Chen J, Tan N, Chen S, Liu Y. Statistical analysis plan for aggressive hydraTion in patients with ST-elevation myocardial infarction undergoing primary percutaneous coronary intervention to prevenT contrast-induced nephropathy (ATTEMPT) study. Ann Transl Med. 2020 Apr;8(7):457. doi: 10.21037/atm.2020.03.192.
Results Reference
derived
PubMed Identifier
31133052
Citation
Song F, Sun G, Liu J, Chen JY, He Y, Liu L, Liu Y; RESCIND group. Efficacy of post-procedural oral hydration volume on risk of contrast-induced acute kidney injury following primary percutaneous coronary intervention: study protocol for a randomized controlled trial. Trials. 2019 May 27;20(1):290. doi: 10.1186/s13063-019-3413-5.
Results Reference
derived
PubMed Identifier
26856220
Citation
Liu Y, Chen JY, Huo Y, Ge JB, Xian Y, Duan CY, Chen SQ, Jiang W, Chen PY, Tan N; RESCIND group. Aggressive hydraTion in patients with ST-Elevation Myocardial infarction undergoing Primary percutaneous coronary intervention to prevenT contrast-induced nephropathy (ATTEMPT): Study design and protocol for the randomized, controlled trial, the ATTEMPT, RESCIND 1 (First study for REduction of contraSt-induCed nephropathy followINg carDiac catheterization) trial. Am Heart J. 2016 Feb;172:88-95. doi: 10.1016/j.ahj.2015.10.007. Epub 2015 Oct 20.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs