The Effect of the Hydroxyethyl Starch on Kidney Injury in Pediatric Cardiac Surgery
1 other identifier
interventional
200
1 country
1
Brief Summary
The investigator will evaluate the influence of colloid administration on postoperative acute kidney injury in pediatric patients undergoing cardiac surgery under cardiopulmonary bypass.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2015
Shorter than P25 for not_applicable
1 active site
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
Study Start
First participant enrolled
November 1, 2015
CompletedFirst Submitted
Initial submission to the registry
November 3, 2015
CompletedFirst Posted
Study publicly available on registry
November 6, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2016
CompletedJune 26, 2017
June 1, 2017
3 months
November 3, 2015
June 22, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Acute Kidney Injury
From the day of surgery to postoperative 7 days
Secondary Outcomes (4)
Blood loss
From the day of surgery to postoperative 7 days
Transfusion amount
From the day of surgery to postoperative 7 days
Mechanical ventilation time
From the day of surgery to postoperative 7 days
Length of ICU stay
From the day of surgery to postoperative 7 days
Study Arms (2)
Crystalloid group
PLACEBO COMPARATORCrystalloid group receive only crystalloid for intravenous volume expansion. The same transfusion protocol is applied in both groups.
Colloid group
ACTIVE COMPARATORColloid group receive colloid preferentially for intravenous volume expansion, until 30 ml/kg. The same transfusion protocol is applied in both groups.
Interventions
normal saline administration for volume expansion in hypovolemic status
HES 130/0.4 administration for volume expansion in hypovolemic status
Eligibility Criteria
You may qualify if:
- Children aged less than 7 years old
- American Society of Anesthesiology (ASA) physical status 1-3
You may not qualify if:
- Preoperative creatinine \> 1.5mg/dl
- History of dialysis
- Liver function abnormality
- Diabetes Mellitus
- History of allergic reaction
- Coagulation abnormality
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seoul national university hospital
Seoul, South Korea
Related Publications (1)
Oh HW, Lee JH, Kim HC, Kim EH, Song IK, Kim HS, Kim JT. The effect of 6% hydroxyethyl starch (130/0.4) on acute kidney injury in paediatric cardiac surgery: a prospective, randomised trial. Anaesthesia. 2018 Feb;73(2):205-215. doi: 10.1111/anae.14129. Epub 2017 Nov 17.
PMID: 29150842DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jin-Tae Kim, PhD
Seoul National University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
November 3, 2015
First Posted
November 6, 2015
Study Start
November 1, 2015
Primary Completion
February 1, 2016
Study Completion
March 1, 2016
Last Updated
June 26, 2017
Record last verified: 2017-06
Data Sharing
- IPD Sharing
- Will not share