Rapid Administration of Insulin in Sepsis
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Purpose
The purpose of this study is to determine if a glucose-insulin-potassium (GIK) solution can be safely administered to patients with septic shock. GIK has been used in thousands of critically ill patients in research studies with very few safety concerns. However, there is a lack of data in regards to patients with septic shock. There are many reasons to believe that GIK would be beneficial in sepsis, including improving heart function and decreasing inflammation. This study will administer intravenous GIK for 12 hours continuously and monitor 10 subjects for 24 hours. A control arm will be used and 10 patients will receive the same monitoring but will not receive GIK.
| Condition | Intervention | Phase |
|---|---|---|
|
Septic Shock |
Drug: GIK |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Rapid Administration of Insulin in Sepsis: A Pilot Study |
- Absolute safety endpoint (explicit definitions) [ Time Frame: During infusion ] [ Designated as safety issue: Yes ]
- Change in SOFA score, microcirculatory flow [ Time Frame: During infusion ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 20 |
| Study Start Date: | March 2009 |
| Study Completion Date: | October 2010 |
| Primary Completion Date: | October 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Glucose-insulin-potassium
|
Drug: GIK
12 hour infusion of GIK solution
|
|
No Intervention: 2
Control
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Suspected or confirmed infection;
Any two of four criteria of systemic inflammatory response:
- Temperature > 100.4° or < 96.8° F
- Heart rate > 90 beats/minute
- Respiratory rate > 20 breaths/min. or PaCO2 < 32 mm Hg
- WBC >12,000 or < 4000 cells/µL or > 10% bands
- Initiation of quantitative resuscitation protocol in the ED;
- Requirement of high dose vasopressors (defined as a cumulative vasopressor index = 4) to treat shock
Exclusion Criteria:
- Age <18 years;
- Pregnancy;
- Any primary diagnosis other than sepsis;
- Established Do Not Resuscitate status or advanced directives restricting aggressive care or treating physician deems aggressive care unsuitable;
- Known hyperkalemia (serum potassium >5.5);
- Dialysis-dependent renal failure;
- Anticipated requirement for immediate surgery (within 24 hours);
- Active participation in another interventional study;
- Transferred from another hospital setting with sepsis therapy initiated;
- Inability to obtain informed consent;
- Cardiopulmonary resuscitation (chest compression or defibrillation) prior to enrollment;
- Active malignancy currently under treatment (chemo- or radiation therapy);
- Known systemic allergy to insulin;
- History of periodic paralysis associated with carbohydrate loading;
- Receiving continuous intravenous inotropic support (including dobutamine, milrinone, amrinone, and levosimendan).
Contacts and Locations| United States, North Carolina | |
| Carolinas Medical Center | |
| Charlotte, North Carolina, United States, 28203 | |
| Study Director: | Alan E Jones, MD | Carolinas Medical Center |
More Information
No publications provided
| Responsible Party: | Alan E. Jones, MD, Carolinas Medical Center |
| ClinicalTrials.gov Identifier: | NCT00823108 History of Changes |
| Other Study ID Numbers: | 12-08-23B |
| Study First Received: | January 14, 2009 |
| Last Updated: | May 31, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Carolinas Healthcare System:
|
GIK, septic shock, sepsis |
Additional relevant MeSH terms:
|
Sepsis Shock Shock, Septic Infection Systemic Inflammatory Response Syndrome Inflammation |
Pathologic Processes Insulin Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 19, 2013