Status:
COMPLETED
Rapid Administration of Insulin in Sepsis
Lead Sponsor:
Wake Forest University Health Sciences
Conditions:
Septic Shock
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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 patie...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2010
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00823108
Start Date
March 1 2009
End Date
October 1 2010
Last Update
April 25 2022
Active Locations (1)
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1
Carolinas Medical Center
Charlotte, North Carolina, United States, 28203