Near Infrared Spectroscopy for the Detection of Acute Kidney Injury in Children Following Cardiac Surgery
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01382758|
Recruitment Status : Completed
First Posted : June 27, 2011
Last Update Posted : January 18, 2013
|Condition or disease|
|Acute Kidney Injury Heart; Dysfunction Postoperative, Cardiac Surgery Children|
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|
|Actual Enrollment :||107 participants|
|Observational Model:||Case Control|
|Official Title:||Use of Near Infrared Spectroscopy (NIRS) for the Early Detection of Acute Kidney Injury in Children Post Cardiopulmonary Bypass|
|Study Start Date :||July 2011|
|Primary Completion Date :||January 2013|
|Study Completion Date :||January 2013|
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
- 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.
- 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.
- 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 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
- 30-day mortality and AKI [ Time Frame: 30 days ]Evaluate the 30-day mortality with regards to presence or absence of AKI
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01382758
|United States, Colorado|
|Children's Hospital Colorado|
|Aurora, Colorado, United States, 80045|
|Principal Investigator:||Katja Gist, DO||Children's Hospital Colorado|