NCT01382758

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
107

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 15, 2011

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 27, 2011

Completed
4 days until next milestone

Study Start

First participant enrolled

July 1, 2011

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

January 18, 2013

Status Verified

June 1, 2012

Enrollment Period

1.5 years

First QC Date

June 15, 2011

Last Update Submit

January 17, 2013

Conditions

Acute Kidney InjuryHeart; Dysfunction Postoperative, Cardiac SurgeryChildren

Keywords

Near Infrared Spectroscopy (NIRS)Acute kidney injury (AKI)

Outcome Measures

Primary Outcomes (1)

  • Acute kidney injury

    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 Outcomes (4)

  • Acute kidney injury by renal biomarkers

    12 hours

  • Mechanical ventilation and acute kidney injury

    Hospital admission (day 1)

  • Hospital length of stay and 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

    30 days

Study Arms (2)

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

Eligibility Criteria

Age1 Day - 4 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

Location

Related Publications (13)

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

    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.

    PMID: 14752434BACKGROUND

  • 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.

    PMID: 18477915BACKGROUND

  • 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.

    PMID: 20606124BACKGROUND

  • 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.

    PMID: 15811456BACKGROUND

  • 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.

    PMID: 16710348BACKGROUND

  • 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.

    PMID: 17396113BACKGROUND

  • 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.

    PMID: 15328595BACKGROUND

  • 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.

    PMID: 18070344BACKGROUND

  • 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.

    PMID: 19570208BACKGROUND

  • 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.

    PMID: 20942931BACKGROUND

  • 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.

    PMID: 11455401BACKGROUND

  • 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.

    PMID: 18337554BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum, Urine

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Katja Gist, DO

    Children's Hospital Colorado

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 15, 2011

First Posted

June 27, 2011

Study Start

July 1, 2011

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

January 18, 2013

Record last verified: 2012-06

Locations

US(1)