Ignite Creation Date:
2024-05-05 @ 12:06 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00240149
Status:
COMPLETED
Last Update Posted:
2007-12-20
First Post:
2005-10-13
Brief Title:
Pilot Study to Evaluate a Method of Controlling High Blood Sugar in the Pediatric Intensive Care Unit
Sponsor:
Stanford University
Organization:
Stanford University
Study Overview
Official Title:
Pilot Study Evaluating Use of Insulin-Glucose Algorithm and Glucose Monitoring Techniques to Control Hyperglycemia in the Pediatric Intensive Care Unit
Status:
COMPLETED
Status Verified Date:
2007-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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-LoopDCL insulin delivery algorithm will be an effective safe and consistent means of delivering insulin to manage glucose in the pediatric intensive care unit
Detailed Description:
The Diabetes Control and Complications Trial DCCT demonstrated that long-term microvascular complications from hyperglycemia could be reduced in adolescents and adults by intensive diabetes management1 Hyperglycemia has also been shown to be an acute risk factor for poor outcome in a variety of adult cases including trauma cardiac2 surgical stroke and head injury patients
Moreover control of hyperglycemia improves the outcome of these critically ill adult patients in intensive care unit ICU settings In a prospective randomized study Van den Berghe et al reported on 1548 patients admitted to an adult surgical ICU During admission intensive treatment with intravenous insulin to control hyperglycemia in both diabetics and non-diabetics reduced the risk of death by 42 overall in-hospital mortality by 34 sepsis by 46 and acute renal failure by 413 Utilizing less stringent criteria for glycemic control Finney et al also reported similar findings4
While these studies have emphasized the value of controlling hyperglycemia in the adult ICU there have been relatively few studies evaluating the incidence of hyperglycemia and its correlates in the PICU and no interventional studies 56
Because of the limited pediatric data available and the impressive findings displayed in the adult literature we performed a retrospective chart review of all pediatric patients admitted to our PICU over a 13 month period The goals of this study were to gain a better understanding of current glucose monitoring techniques in the PICU as well how hyperglycemia correlates with morbidity and mortality in pediatrics
The results confirmed our hypothesis that a higher peak glucose during an admission is associated with longer LOS and a higher mortality rate 7
As demonstrated in adults control of hyperglycemia has the potential to have a profound impact on the morbidity and mortality of patients in the PICU Our preliminary study clearly showed that hyperglycemia is associated with increased LOS and mortality Unfortunately the true clinical impact of controlling hyperglycemia on pediatric ICU patients is not known By more accurately and more safely controlling hyperglycemia in the PICU we have the opportunity to improve on the standard of care as well as to potentially improve the overall clinical outcome of PICU patients Once the use of an insulin delivery algorithm and our methods for glucose monitoring have been explored in this randomized controlled feasibility study this form of improved glucose management can be formally tested in a large multi-center trial in the PICU setting
Moreover control of hyperglycemia improves the outcome of these critically ill adult patients in intensive care unit ICU settings In a prospective randomized study Van den Berghe et al reported on 1548 patients admitted to an adult surgical ICU During admission intensive treatment with intravenous insulin to control hyperglycemia in both diabetics and non-diabetics reduced the risk of death by 42 overall in-hospital mortality by 34 sepsis by 46 and acute renal failure by 413 Utilizing less stringent criteria for glycemic control Finney et al also reported similar findings4
While these studies have emphasized the value of controlling hyperglycemia in the adult ICU there have been relatively few studies evaluating the incidence of hyperglycemia and its correlates in the PICU and no interventional studies 56
Because of the limited pediatric data available and the impressive findings displayed in the adult literature we performed a retrospective chart review of all pediatric patients admitted to our PICU over a 13 month period The goals of this study were to gain a better understanding of current glucose monitoring techniques in the PICU as well how hyperglycemia correlates with morbidity and mortality in pediatrics
The results confirmed our hypothesis that a higher peak glucose during an admission is associated with longer LOS and a higher mortality rate 7
As demonstrated in adults control of hyperglycemia has the potential to have a profound impact on the morbidity and mortality of patients in the PICU Our preliminary study clearly showed that hyperglycemia is associated with increased LOS and mortality Unfortunately the true clinical impact of controlling hyperglycemia on pediatric ICU patients is not known By more accurately and more safely controlling hyperglycemia in the PICU we have the opportunity to improve on the standard of care as well as to potentially improve the overall clinical outcome of PICU patients Once the use of an insulin delivery algorithm and our methods for glucose monitoring have been explored in this randomized controlled feasibility study this form of improved glucose management can be formally tested in a large multi-center trial in the PICU setting
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NIH Training Grant - DK07217 | None | None | None |
| Medtronic Minimed - Pending | None | None | None |