Clinical trial NCT02067195: Aggressive hydraTion in Patients With ST -Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention to prevenT Contrast-Induced Nephropathy
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
Overall status: UNKNOWN
Phase: NA
Conditions: ST Elevation Myocardial Infarction
Keywords: acute myocardial infarction,contrast,coronary intervention
Lead sponsor: Guangdong Provincial People's Hospital
Sponsor class: OTHER
Collaborators: name: Peking University First Hospital
name: Chinese PLA General Hospital
name: Fudan University
First posted: 2014-02-20
Enrollment: 560
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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 )

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。

Primary outcomes:
measure: Contrast-Induced Nephropathy
timeFrame: 72 hours
measure: Contrast Induced Acute Kidney Injury
timeFrame: 24 hours
Secondary outcomes:
measure: contrast-induced acute kidney injury
timeFrame: 48 hours
measure: Composite contrast-induced acute kidney injury
timeFrame: 48 hours
measure: Persistent renal damage
timeFrame: 3 months
measure: Alteration of renal function
timeFrame: 72 hours
measure: Severe adverse renal events
timeFrame: 1 year
measure: Major adverse cardiovascular events
timeFrame: 1 year
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangdong General Hospital
state: Guangdong
Study officials:
affiliation: Guangdong Cardiovascular Institute,Guangdong General Hospital
name: Jiyan Chen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Guangdong Cardiovascular Institute,Guangdong General Hospital
name: Yong Liu, MD
role: STUDY_DIRECTOR
References:
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.
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.
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.
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.