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

NCT02067195 | Unknown DMC

• 1 other identifier: CSC20140222
• Study Type: interventional
• Target: 560
• Locations: 1 country
• Sites: 1

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.

Conditions

ST Elevation Myocardial Infarction

Keywords

acute myocardial infarction,contrast,coronary intervention

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Secondary Outcomes (6)

• 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

Study Arms (2)

Guideline Hydration

ACTIVE COMPARATOR

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)

Adequate Hydration

ACTIVE COMPARATOR

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)

Interventions

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

Also known as: Guideline Hydration

Guideline Hydration

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

Also known as: Adequate Hydration

Adequate Hydration

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• all consecutive patients with STEMI, age at least 18 years, who were candidates for primary PCI were considered for enrollment.

You may not qualify if:

• 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。

Sponsors & Collaborators

• Guangdong Provincial People's Hospital: lead
• Peking University First Hospital: collaborator
• Chinese PLA General Hospital: collaborator
• Fudan University: collaborator

Study Sites (1)

Guangdong General Hospital

Guangzhou, Guangdong, 501080, China

RECRUITING

Related Publications (4)

• 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.

  PMID: 32580757 DERIVED

• 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.

  PMID: 32395501 DERIVED

• 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.

  PMID: 31133052 DERIVED

• 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.

  PMID: 26856220 DERIVED

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Jiyan Chen, MD

  Guangdong Cardiovascular Institute,Guangdong General Hospital

  PRINCIPAL INVESTIGATOR

• Yong Liu, MD

  Guangdong Cardiovascular Institute,Guangdong General Hospital

  STUDY DIRECTOR

Central Study Contacts

Jiyan Chen, MD

CONTACT

86-20-83827812; chenjiyandr@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: February 16, 2014
• First Posted: February 20, 2014
• Study Start: July 1, 2014
• Primary Completion: March 1, 2016
• Study Completion: July 1, 2017
• Last Updated: August 21, 2015

Record last verified: 2015-08

Locations

CN (1)