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

NCT ID: NCT01382758

Last Updated: 2013-01-18

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 107 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-07-31
• Study Completion Date: 2013-01-31

Brief Summary

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.

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.

Conditions

Acute Kidney Injury; Heart; Dysfunction Postoperative, Cardiac Surgery; Children

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Acute kidney injury

The group of patients who develop acute kidney injury as defined by the pediatric RIFLE criteria.

No interventions assigned to this group

No acute kidney injury

The patients who do not develop acute kidney injury

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 1 Day
• Maximum Eligible Age: 4 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Katja Gist, DO

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital Colorado

Locations

Children's Hospital Colorado

Aurora, Colorado, United States

Countries

United States

References

Wider M. Monitoring regional hemoglobin oxygen saturation (rSO2) of the kidney and gut. Somanetics corporation

Reference Type: BACKGROUND

Hoffman GM, Stuth EA, Jaquiss RD, Vanderwal PL, Staudt SR, Troshynski TJ, Ghanayem NS, Tweddell JS. Changes in cerebral and somatic oxygenation during stage 1 palliation of hypoplastic left heart syndrome using continuous regional cerebral perfusion. J Thorac Cardiovasc Surg. 2004 Jan;127(1):223-33. doi: 10.1016/j.jtcvs.2003.08.021.

Reference Type: BACKGROUND

PMID: 14752434 (View on PubMed)

Kaufman J, Almodovar MC, Zuk J, Friesen RH. Correlation of abdominal site near-infrared spectroscopy with gastric tonometry in infants following surgery for congenital heart disease. Pediatr Crit Care Med. 2008 Jan;9(1):62-8. doi: 10.1097/01.PCC.0000298640.47574.DA.

Reference Type: BACKGROUND

PMID: 18477915 (View on PubMed)

Kussman BD, Wypij D, Laussen PC, Soul JS, Bellinger DC, DiNardo JA, Robertson R, Pigula FA, Jonas RA, Newburger JW. Relationship of intraoperative cerebral oxygen saturation to neurodevelopmental outcome and brain magnetic resonance imaging at 1 year of age in infants undergoing biventricular repair. Circulation. 2010 Jul 20;122(3):245-54. doi: 10.1161/CIRCULATIONAHA.109.902338. Epub 2010 Jul 6.

Reference Type: BACKGROUND

PMID: 20606124 (View on PubMed)

Mishra J, Dent C, Tarabishi R, Mitsnefes MM, Ma Q, Kelly C, Ruff SM, Zahedi K, Shao M, Bean J, Mori K, Barasch J, Devarajan P. Neutrophil gelatinase-associated lipocalin (NGAL) as a biomarker for acute renal injury after cardiac surgery. Lancet. 2005 Apr 2-8;365(9466):1231-8. doi: 10.1016/S0140-6736(05)74811-X.

Reference Type: BACKGROUND

PMID: 15811456 (View on PubMed)

Parikh CR, Mishra J, Thiessen-Philbrook H, Dursun B, Ma Q, Kelly C, Dent C, Devarajan P, Edelstein CL. Urinary IL-18 is an early predictive biomarker of acute kidney injury after cardiac surgery. Kidney Int. 2006 Jul;70(1):199-203. doi: 10.1038/sj.ki.5001527. Epub 2006 May 17.

Reference Type: BACKGROUND

PMID: 16710348 (View on PubMed)

Akcan-Arikan A, Zappitelli M, Loftis LL, Washburn KK, Jefferson LS, Goldstein SL. Modified RIFLE criteria in critically ill children with acute kidney injury. Kidney Int. 2007 May;71(10):1028-35. doi: 10.1038/sj.ki.5002231. Epub 2007 Mar 28.

Reference Type: BACKGROUND

PMID: 17396113 (View on PubMed)

Ferrari M, Mottola L, Quaresima V. Principles, techniques, and limitations of near infrared spectroscopy. Can J Appl Physiol. 2004 Aug;29(4):463-87. doi: 10.1139/h04-031.

Reference Type: BACKGROUND

PMID: 15328595 (View on PubMed)

Dent CL, Ma Q, Dastrala S, Bennett M, Mitsnefes MM, Barasch J, Devarajan P. Plasma neutrophil gelatinase-associated lipocalin predicts acute kidney injury, morbidity and mortality after pediatric cardiac surgery: a prospective uncontrolled cohort study. Crit Care. 2007;11(6):R127. doi: 10.1186/cc6192.

Reference Type: BACKGROUND

PMID: 18070344 (View on PubMed)

Liu KD, Altmann C, Smits G, Krawczeski CD, Edelstein CL, Devarajan P, Faubel S. Serum interleukin-6 and interleukin-8 are early biomarkers of acute kidney injury and predict prolonged mechanical ventilation in children undergoing cardiac surgery: a case-control study. Crit Care. 2009;13(4):R104. doi: 10.1186/cc7940. Epub 2009 Jul 1.

Reference Type: BACKGROUND

PMID: 19570208 (View on PubMed)

Dennen P, Altmann C, Kaufman J, Klein CL, Andres-Hernando A, Ahuja NH, Edelstein CL, Cadnapaphornchai MA, Keniston A, Faubel S. Urine interleukin-6 is an early biomarker of acute kidney injury in children undergoing cardiac surgery. Crit Care. 2010;14(5):R181. doi: 10.1186/cc9289. Epub 2010 Oct 13.

Reference Type: BACKGROUND

PMID: 20942931 (View on PubMed)

Kist-van Holthe tot Echten JE, Goedvolk CA, Doornaar MB, van der Vorst MM, Bosman-Vermeeren JM, Brand R, van der Heijden AJ, Schoof PH, Hazekamp MG. Acute renal insufficiency and renal replacement therapy after pediatric cardiopulmonary bypass surgery. Pediatr Cardiol. 2001 Jul-Aug;22(4):321-6. doi: 10.1007/s002460010238.

Reference Type: BACKGROUND

PMID: 11455401 (View on PubMed)

Bennett M, Dent CL, Ma Q, Dastrala S, Grenier F, Workman R, Syed H, Ali S, Barasch J, Devarajan P. Urine NGAL predicts severity of acute kidney injury after cardiac surgery: a prospective study. Clin J Am Soc Nephrol. 2008 May;3(3):665-73. doi: 10.2215/CJN.04010907. Epub 2008 Mar 12.

Reference Type: BACKGROUND

PMID: 18337554 (View on PubMed)

Other Identifiers

AAP11-0527

Identifier Type: OTHER

Identifier Source: secondary_id

11-0527

Identifier Type: -

Identifier Source: org_study_id