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

NCT ID: NCT02067195

Last Updated: 2015-08-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 560 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-31
• Study Completion Date: 2017-07-31

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 )

Conditions

ST Elevation Myocardial Infarction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: DRUG

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

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.

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Guideline Hydration; 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。

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking University First Hospital

OTHER

Sponsor Role: collaborator

Chinese PLA General Hospital

OTHER

Sponsor Role: collaborator

Fudan University

OTHER

Sponsor Role: collaborator

Guangdong Provincial People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jiyan Chen

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jiyan Chen, MD

Role: PRINCIPAL_INVESTIGATOR

Guangdong Cardiovascular Institute,Guangdong General Hospital

Yong Liu, MD

Role: STUDY_DIRECTOR

Guangdong Cardiovascular Institute,Guangdong General Hospital

Locations

Guangdong General Hospital

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Jiyan Chen, MD

Role: CONTACT

chenjiyandr@126.com

86-20-83827812 ext. 10528

Facility Contacts

Yong Liu, MD

Role: primary

liuyong2099@126.com

86-20-83827812 ext. 10528

References

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.

Reference Type: DERIVED

PMID: 32580757 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 32395501 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 31133052 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 26856220 (View on PubMed)

Other Identifiers

CSC20140222

Identifier Type: -

Identifier Source: org_study_id