NCT02232997

Brief Summary

No well-defined protocols exist to guide fluid administration for prevention of contrast-associated acute kidney injury in high risk patients. The investigators will compare long term hydration at routine speed(12h before and after procedure at 1ml/kg/h) with short term hydration at high speed(1h before and 4h after procedure at 3ml/kg/h) to verify our hypothesis that the short term hydration may not be inferior to the long one.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,002

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 1, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 8, 2014

Completed
7 months until next milestone

Study Start

First participant enrolled

April 1, 2015

Completed
6.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

October 3, 2022

Status Verified

September 1, 2022

Enrollment Period

6.7 years

First QC Date

September 1, 2014

Last Update Submit

September 29, 2022

Conditions

Chronic Kidney Disease

Keywords

Contrast-associated acute kidney injuryCoronary angiographyChronic kidney diseaseIntravenous hydration

Outcome Measures

Primary Outcomes (1)

  • Contrast-associated acute kidney injury a

    Defined as ≥25% or 0.5 mg/dL absolute increase in serum creatinine from baseline during the first 48-72 hours after the procedure

    72 hours

Secondary Outcomes (11)

  • Number of Participants with Acute heart failure

    post-procedural during hospitalization, an average of 3 days

  • Contrast-associated acute kidney injury b

    72 hours

  • Contrast-associated acute kidney injury c

    24 hours

  • Contrast-associated acute kidney injury d

    48 hours

  • Contrast-associated acute kidney injury e

    24 hours

  • +6 more secondary outcomes

Study Arms (2)

Standard Hydration

ACTIVE COMPARATOR

Standard long-term hydration, i.e. hydrated with normal saline 12 hours before and 12 hours after coronary intervention at a rate of 1 ml/kg/h

Other: Standard Hydration

Simplified Hydration

ACTIVE COMPARATOR

Rapid short-term hydration, i.e. hydrated with normal saline from 1 hour before to 4 hours after coronary intervention at a rate of 3 ml/kg/h

Other: Simplified Hydration

Interventions

Standard HydrationOTHER

Sodium chloride hydration was set between 12 hours before coronary intervention (before contrast exposure during coronary angiography), continued during procedure, and 12 hours after procedure at 1 ml/kg/h (0.5 ml/kg/h For patients with congestive heart failure, New York Heart Association class\>II, or LVEF \< 35%). For patients weighing more than 80 kg, bolus and infusion rates are limited to calculated values for patients weighing 80 kg

Also known as: The control hydration group
Standard Hydration
Simplified HydrationOTHER

Hydration with sodium chloride was set 1 hour before procedure (before contrast exposure during coronary angiography), continued during procedure, and 4 hours after procedure at 3ml/kg/h (1.5ml/kg/h For patients with congestive heart failure, New York Heart Association class\>II, or LVEF \<35%). For patients weighing more than 80 kg, bolus and infusion rates are limited to those calculated for patients weighing 80 kg.

Also known as: The simple hydration group
Simplified Hydration

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ≥18 years of age;
  • Written informed consent;
  • Candidates scheduled for coronary intervention (angiography and/or coronary intervention);
  • Patients with chronic renal insufficiency, the baseline estimated glomerular filtration rate (eGFR) was 15-60 mL/min / 1.73 m²
  • At least one risk factor (age\>75 years, medical history of diabetes mellitus or hypertension, congestive heart failure \[NYHA class \>II or history of acute pulmonary edema\]);

You may not qualify if:

  • End-stage renal failure or heart/renal transplantation;
  • History of exposure to contrast medium or acute infectious diseases within 48 hours prior to the procedure;
  • Acute decompensated heart failure;
  • Left ventricular thrombus;
  • Allergy to contrast agent;
  • Pregnancy or lactation;
  • Malignant tumour or life expectancy \<1 year;
  • Pre-procedural receipt of NSAIDs (except Asprin), aminoglycosides, cyclosporine or cisplatin in the past 48 h;
  • Severe valve disease or elective undergoing surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, 501080, China

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jiyan Chen, MD

    Guangdong Cardiovascular Institute, Guangdong Provincial People's Hospital

    STUDY CHAIR

  • Yong Liu, MD

    Guangdong Cardiovascular Institute, Guangdong Provincial People's Hospital

    STUDY DIRECTOR

  • Yong Huo, MD

    Peking University First Hospital

    PRINCIPAL INVESTIGATOR

  • Junbo Ge, MD

    Fudan University

    PRINCIPAL INVESTIGATOR

  • Pingyan Chen, MS

    Southern Medical University

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

September 1, 2014

First Posted

September 8, 2014

Study Start

April 1, 2015

Primary Completion

December 1, 2021

Study Completion

December 1, 2021

Last Updated

October 3, 2022

Record last verified: 2022-09

Locations

CN(1)