Pilot Study to Evaluate a Method of Controlling High Blood Sugar in the Pediatric Intensive Care Unit

NCT00240149 | Completed

• 3 other identifiers: 95771Medtronic Minimed - PendingNIH Training Grant - DK07217
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

Brief Summary

Recent studies of adult intensive care unit (ICU) patients have shown significantly decreased morbidity and mortality when blood sugar concentrations are closely controlled. The safety and efficacy of this type of blood sugar management has not been studied in the pediatric ICU population. Based on the current pediatric literature data as well as our extensive retrospective study, blood sugar concentrations have a potentially profound role to play among PICU patients. In preparation for a multi-center randomized control trial, we propose a prospective feasibility study to evaluate the safety and effectiveness of using an insulin delivery algorithm to manage blood sugar in the PICU. Our hypothesis for this feasibility trial is that uniformly monitoring and controlling blood glucose with a Discrete-Closed-Loop(DCL) insulin delivery algorithm will be an effective, safe, and consistent means of delivering insulin to manage glucose in the pediatric intensive care unit.

Conditions

Hyperglycemia

Outcome Measures

Primary Outcomes (5)

• Specific Aim #1 Intervention): Randomized study of strict glucose control in a pediatric intensive care unit (PICU) using a discrete-closed-loop (DCL) insulin algorithm.

• Safely reach and maintain a glucose range goal of 90-120 mg/dl in the treatment group within 4 hrs of initiating therapy.

• Maintain at least 90% of glucose values within the target range.

• Have fewer than 1% of glucose values below 50 mg/dl.

• d) Show a significant difference in glucose values (mean glucose values and area under the curve) between the Treatment and Control group.

Interventions

Regular Insulin via Insulin-Glucose Algorithm DRUG

Eligibility Criteria

• Age: 1 Year - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients between 1-18 years of age admitted to the PICU at LPCH will be asked to participate in a randomized feasibility trial during their hospitalization. This initial age restriction will be adjusted as experience is gained.

You may not qualify if:

• Patients who are known to be pregnant will be excluded.
• Patients who have known platelet dysfunction will be excluded.
• Patients without intact, uninfected skin at the future site of sensor insertion.
• Study patients re-admitted to the PICU after hospital discharge will not be eligible for repeat participation

Sponsors & Collaborators

• Stanford University: lead
• Medtronic: collaborator

Study Sites (2)

Lucile Packard Childrens Hospital - PICU

Stanford, California, 94305, United States

Location

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

Related Publications (7)

• Diabetes Control and Complications Trial Research Group; Nathan DM, Genuth S, Lachin J, Cleary P, Crofford O, Davis M, Rand L, Siebert C. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. N Engl J Med. 1993 Sep 30;329(14):977-86. doi: 10.1056/NEJM199309303291401.

  PMID: 8366922 BACKGROUND

• Finney SJ, Zekveld C, Elia A, Evans TW. Glucose control and mortality in critically ill patients. JAMA. 2003 Oct 15;290(15):2041-7. doi: 10.1001/jama.290.15.2041.

  PMID: 14559958 BACKGROUND

• Capes SE, Hunt D, Malmberg K, Gerstein HC. Stress hyperglycaemia and increased risk of death after myocardial infarction in patients with and without diabetes: a systematic overview. Lancet. 2000 Mar 4;355(9206):773-8. doi: 10.1016/S0140-6736(99)08415-9.

  PMID: 10711923 BACKGROUND

• van den Berghe G, Wouters P, Weekers F, Verwaest C, Bruyninckx F, Schetz M, Vlasselaers D, Ferdinande P, Lauwers P, Bouillon R. Intensive insulin therapy in critically ill patients. N Engl J Med. 2001 Nov 8;345(19):1359-67. doi: 10.1056/NEJMoa011300.

  PMID: 11794168 BACKGROUND

• Cochran A, Scaife ER, Hansen KW, Downey EC. Hyperglycemia and outcomes from pediatric traumatic brain injury. J Trauma. 2003 Dec;55(6):1035-8. doi: 10.1097/01.TA.0000031175.96507.48.

  PMID: 14676647 BACKGROUND

• Srinivasan V, Spinella PC, Drott HR, Roth CL, Helfaer MA, Nadkarni V. Association of timing, duration, and intensity of hyperglycemia with intensive care unit mortality in critically ill children. Pediatr Crit Care Med. 2004 Jul;5(4):329-36. doi: 10.1097/01.pcc.0000128607.68261.7c.

  PMID: 15215001 BACKGROUND

• Wintergerst KA, Deiss D, Buckingham B, Cantwell M, Kache S, Agarwal S, Wilson DM, Steil G. Glucose control in pediatric intensive care unit patients using an insulin-glucose algorithm. Diabetes Technol Ther. 2007 Jun;9(3):211-22. doi: 10.1089/dia.2006.0031.

  PMID: 17561791 BACKGROUND

MeSH Terms

Conditions

Hyperglycemia

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Bruce A. Buckingham

  Stanford University

  SUB INVESTIGATOR

• Darrell M Wilson

  Stanford University

  SUB INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 13, 2005
• First Posted: October 17, 2005
• Study Start: October 1, 2005
• Study Completion: March 1, 2006
• Last Updated: December 20, 2007

Record last verified: 2007-11

Locations

US (2)