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

NCT02067195 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 560

Last updated 2015-08-21

No results posted yet for this study

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

Interventions

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.

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.

Sponsors & Collaborators

  • Peking University First Hospital

    collaborator OTHER

  • Chinese PLA General Hospital

    collaborator OTHER

  • Fudan University

    collaborator OTHER

  • Guangdong Provincial People's Hospital

    lead OTHER

Principal Investigators

  • Jiyan Chen, MD · Guangdong Cardiovascular Institute,Guangdong General Hospital

  • Yong Liu, MD · Guangdong Cardiovascular Institute,Guangdong General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-07-31
Primary Completion
2016-03-31
Completion
2017-07-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02067195 on ClinicalTrials.gov