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Completed

NCT Number: NCT02599155

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

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

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Key information

Conditions

Acute Kidney Injury Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

Up to 7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul national university hospital

Seoul, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Crystalloid

Drug

normal saline administration for volume expansion in hypovolemic status

Other names: normal saline

colloid

Drug

HES 130/0.4 administration for volume expansion in hypovolemic status

Other names: HES 130/0.4

Primary outcomes

  1. Acute Kidney Injury

    Time frame: From the day of surgery to postoperative 7 days

Secondary outcomes

  1. Blood loss

    Time frame: From the day of surgery to postoperative 7 days

  2. Transfusion amount

    Time frame: From the day of surgery to postoperative 7 days

  3. Mechanical ventilation time

    Time frame: From the day of surgery to postoperative 7 days

  4. Length of ICU stay

    Time frame: From the day of surgery to postoperative 7 days

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Nov 6, 2015
Registry last updated
Jun 26, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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