Saraswati Kache
Pilot Study to Evaluate a Method of Controlling High Blood Sugar in the Pediatric Intensive Care Unit
Contact Information
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Brief
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.
Recruiting Status:
CompletedStanford Recruiting Status:
CompletedCondition(s):
Intervention(s):
- Drug: Regular Insulin via Insulin-Glucose Algorithm
Phase:
N/AEligibility
Ages Eligible for Study:
1 years to 18 yearsGenders Eligible for Study:
Male and FemaleHealth of Volunteers:
People with the conditions listed in this trial can participate as controls.Key Inclusion Criteria:
:
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.
Patient displays evidence of hyperglycemia (>150mg/dl)
Key Exclusion Criteria:
Initially, patients younger than 5 years of age will be excluded. These patients appear to have a higher sensitivity to insulin as well as a proposed higher risk of hypoglycemia. Since this is a feasibility trial using insulin to control glucose, we feel that it would be prudent to establish success in an older patient population before extending the study to include younger children and infants. In addition, our PICU study revealed no significant increased risk of hyperglycemia based on age. This age restriction will be adjusted after the mid-study data analysis.
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
Additional Study Details
Official Title:
Pilot Study Evaluating Use of Insulin-Glucose Algorithm and Glucose Monitoring Techniques to Control Hyperglycemia in the Pediatric Intensive Care UnitAnticipated start date:
10/1/2005Lead Sponsor:
Stanford UniversityCollaborator(s):
- Medtronic Minimed, Inc.
Investigator(s):
- Bruce A. Buckingham
- Darrell M Wilson
- Saraswati Kache MD
- Kupper Anthony Wintergerst
- Dorothee Deiss
- Lorry R Frankel
- Swati Agarwal
Study Type:
InterventionalPurpose:
TreatmentAllocation:
RandomizedMasking:
OpenControl:
noneAssignment:
Single GroupEndpoints:
UnspecifiedPrimary Outcomes:
- 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.
Total Number to be Enrolled:
0Total Number to be Enrolled at Stanford:
0More Information
Publications About this Study:
- 8366922: [No authors listed] The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. The Diabetes Control and Complications Trial Research Group. N Engl J Med. 1993 Sep 30;329(14):977-86.
- 14559958: Finney SJ, Zekveld C, Elia A, Evans TW. Glucose control and mortality in critically ill patients. JAMA. 2003 Oct 15;290(15):2041-7.
- 10711923: 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. Review.
- 11794168: 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 the critically ill patients. N Engl J Med. 2001 Nov 8;345(19):1359-67.
- 14676647: Cochran A, Scaife ER, Hansen KW, Downey EC. Hyperglycemia and outcomes from pediatric traumatic brain injury. J Trauma. 2003 Dec;55(6):1035-8.
- 15215001: 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.
- 00000000: Wintergerst KA, Buckingham B, Gandrud L, Kache S, Wilson DM. Hyperglycemia in the Pediatric Intensive Care Unit. Abstract. Diabetes Technology & Therapeutics 7(2):422, 2005.
Secondary ID(s):
- Medtronic Minimed - Pending
- NIH Training Grant - DK07217
Locations & Contacts
Stanford Locations & Contacts:
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Non-Stanford Locations:
This study is being conducted at multiple locations, including non-Stanford locations.
This listing was last updated:
11/1/2007PLEASE NOTE:
Study Coordinators and Research Nurses cannot give medical advice over the phone. Telephone numbers are provided for obtaining additional information on specific clinical research trials only. If you have specific questions which require clinical expertise, please call your primary care physician. If you do not have a primary care physician please feel free to call the SHC Physician Referral Service at (800) 756-9000 or send an email.
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