Near Infrared Spectroscopy for the Detection of Acute Kidney Injury in Children Following Cardiac Surgery

January 17, 2013 updated by: University of Colorado, Denver

Use of Near Infrared Spectroscopy (NIRS) for the Early Detection of Acute Kidney Injury in Children Post Cardiopulmonary Bypass

One in a hundred children is born with a heart defect. Some children require heart surgery within the first few days of life, while others can wait until they are older. A complication of open-heart surgery is low blood flow due to the heart-lung machine that can cause sudden loss of kidney function known as acute kidney injury (AKI). AKI causes complications that can increase hospital length of stay and increase risk of death. Current ways to identify AKI are not able to it until 2 or 3 days after it has occurred. Because of this, there is not a specific treatment for AKI. If the investigators diagnose AKI early, they might be able to treat it and improve outcomes in children. NIRS is a skin monitor that can detect low blood flow to the kidney and might help diagnose AKI when it occurs in the operating room. The use of NIRS to diagnose AKI early is the focus of this study.

Study Overview

Status

Completed

Conditions

Detailed Description

Near infrared spectroscopy (NIRS) is a noninvasive tool used for continuous monitoring of regional tissue oxyhemoglobin saturation. Sensors are placed on the head and abdomen or flank and use light to measure the percent oxygen levels in tissues. Head NIRS has been correlated with oxygen levels of the blood returning from the brain, and an abrupt decline in post-operative cardiac patients has been shown in retrospective studies to predict an impending event such as cardiac arrest. Animal studies have demonstrated that somatic NIRS monitoring is able to detect flow-induced changes in regional oxygen levels of the kidney and gut directly under the sensor. Unlike cerebral NIRS monitoring, there is no data regarding the clinical utility of NIRS over the abdomen and flank in predicting outcomes. Children are at risk of decreased organ perfusion following cardiac surgery, and is a phenomenon termed low cardiac output syndrome (LCOS). It occurs in approximately 25% of neonates and young children following cardiac surgery. The effects of LCOS on end organ function, specifically the kidney may result in acute kidney injury, thereby increasing morbidity and mortality. The incidence of acute kidney injury (AKI) following cardiac surgery is reported as high as 40%. The use of NIRS in the operating room to detect AKI in pediatric patients undergoing cardiac surgery is the focus of this proposal Specific Aim 1: Determine if a reduction in renal NIRS intra-operatively identifies patients with AKI Hypothesis: Reduced intra-operative renal NIRS will precede the diagnosis of acute kidney injury by an increase in serum creatinine within 1 to 3 days post-cardiopulmonary bypass Specific Aim 2: Determine if a reduction in renal NIRS intra-operatively correlates with increases in emerging biomarkers of AKI.

Hypothesis: Reduced intra-operative renal NIRS will precede the development if AKI as detected by neutrophil gelatinase-associated lipocalin, IL-6 and IL-18 by at least 2 hours.

Study Type

Observational

Enrollment (Actual)

107

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Children's Hospital Colorado

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 4 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All children undergoing cardiac surgery with the use of cardiopulmonary bypass at our institution.

Description

Inclusion Criteria:

  • All children less than or equal to age 4 undergoing cardiac surgery with the use of cardiopulmonary bypass at Colorado Children's Hospital

Exclusion Criteria:

  • Prior enrollment in the study
  • Agre greater than 4 years
  • Use of nephrotoxic drugs within 48 hours of surgery
  • Underlying renal dysfunction (preoperative estimated Schwartz clearance less than 80ml/min/1.73m2)
  • Gestational age less than 34 weeks at the time of surgery
  • Withdrawal of care planned

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Acute kidney injury
The group of patients who develop acute kidney injury as defined by the pediatric RIFLE criteria.
No acute kidney injury
The patients who do not develop acute kidney injury

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acute kidney injury
Time Frame: 48-72 hours
A decline in intra-operative renal NIRS to predict AKI as measured by an increase in serum creatinine. Baseline lab testing, including BMP, UA. Renal NIRS sensors will be placed prior surgery. In the OR, continuous real time monitoring of NIRS will occur and continue for 72 hours after cardiopulmonary bypass (CPB). BMP will be performed after surgery and at 24, 48 and 72 hours. Repeat UA will be performed at 24 hours post CPB, and urine electrolytes and urea will be performed at 12, 24, 48 and 72 hours. AKI as defined by the pRIFLE criteria at 48-72 hours post cardiopulmonary bypass.
48-72 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acute kidney injury by renal biomarkers
Time Frame: 12 hours
NIRS monitoring as described above. Baseline renal biomarkers (urine: NGAL, IL-18, IL-6, serum: IL-6, IL-8) followed by repeated sampling at 6, 12, 24, 48 and 72 hours post initiation of CPB. Serum sampling will last only occur through 24 hours.
12 hours
Mechanical ventilation and acute kidney injury
Time Frame: Hospital admission (day 1)
Duration of mechanical ventilation, including any failures of extubation. Will include ventilator parameters (inspired oxygen, peak pressures)
Hospital admission (day 1)
Hospital length of stay and AKI
Time Frame: An average of 1 week for simple defects and 4 weeks for complex congenital heart defects (Hypoplastic left heart syndrome)
Evaluate intensive care and hospital length of stay with regards to presence or absence of AKI
An average of 1 week for simple defects and 4 weeks for complex congenital heart defects (Hypoplastic left heart syndrome)
30-day mortality and AKI
Time Frame: 30 days
Evaluate the 30-day mortality with regards to presence or absence of AKI
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Colorado, Denver

Investigators

  • Principal Investigator: Katja Gist, DO, Children's Hospital Colorado

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2011

Primary Completion (ACTUAL)

January 1, 2013

Study Completion (ACTUAL)

January 1, 2013

Study Registration Dates

First Submitted

June 15, 2011

First Submitted That Met QC Criteria

June 24, 2011

First Posted (ESTIMATE)

June 27, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

January 18, 2013

Last Update Submitted That Met QC Criteria

January 17, 2013

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11-0527
  • AAP11-0527 (OTHER)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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