The Effect of the Hydroxyethyl Starch on Kidney Injury in Pediatric Cardiac Surgery

Acute Kidney Injury Clinical Trial

Official title:

The Effect of the Hydroxyethyl Starch on Kidney Injury in Pediatric Cardiac Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02599155
• Other study ID #: H1507-061-687
• Status: Completed
• Phase: N/A
• First received: November 3, 2015
• Last updated: June 22, 2017
• Start date: November 2015
• Est. completion date: March 2016

Study information

• Verified date: June 2017
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The investigator will evaluate the influence of colloid administration on postoperative acute kidney injury in pediatric patients undergoing cardiac surgery under cardiopulmonary bypass.

Description:

The investigator will randomly divide pediatric patients aged less than 7 years old into crystalloid and colloid groups. Crystalloid group receive only crystalloid, and colloid group receive hydroxyethyl starch (HES, 130/0.4). The maximum volume of HES is limited less than 30 ml/kg. The same transfusion protocol will be applied in both groups. From the day of operation to postoperative 7 days, glomerular filtration rate (GFR), serum creatinin level (Cr) will be checked. Acute kidney injury (AKI) is defined when there is more than 50% increase in Cr when compared to baseline level. The investigator will compare the clinical outcomes including AKI between two groups.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: March 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 7 Years

Eligibility

Inclusion Criteria:

• Children aged less than 7 years old

• American Society of Anesthesiology (ASA) physical status 1-3

Exclusion Criteria:

• Preoperative creatinine > 1.5mg/dl

• History of dialysis

• Liver function abnormality

• Diabetes Mellitus

• History of allergic reaction

• Coagulation abnormality

Related Conditions & MeSH terms

• Acute Kidney Injury
• Wounds and Injuries

Intervention

Drug:
• Crystalloid
normal saline administration for volume expansion in hypovolemic status
• Colloid
HES 130/0.4 administration for volume expansion in hypovolemic status

Locations

Country	Name	City	State
Korea, Republic of	Seoul national university hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acute Kidney Injury		From the day of surgery to postoperative 7 days
Secondary	Blood loss		From the day of surgery to postoperative 7 days
Secondary	Transfusion amount		From the day of surgery to postoperative 7 days
Secondary	Mechanical ventilation time		From the day of surgery to postoperative 7 days
Secondary	Length of ICU stay		From the day of surgery to postoperative 7 days