Rapid Administration of Insulin in Sepsis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00823108
Recruitment Status : Completed
First Posted : January 15, 2009
Last Update Posted : June 1, 2011
Information provided by:
Carolinas Healthcare System

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 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 or disease Intervention/treatment Phase
Septic Shock Drug: GIK Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Rapid Administration of Insulin in Sepsis: A Pilot Study
Study Start Date : March 2009
Actual Primary Completion Date : October 2010
Actual Study Completion Date : October 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis Shock

Arm Intervention/treatment
Experimental: 1
Drug: GIK
12 hour infusion of GIK solution

No Intervention: 2

Primary Outcome Measures :
  1. Absolute safety endpoint (explicit definitions) [ Time Frame: During infusion ]
  2. Change in SOFA score, microcirculatory flow [ Time Frame: During infusion ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Suspected or confirmed infection;
  2. 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
  3. Initiation of quantitative resuscitation protocol in the ED;
  4. Requirement of high dose vasopressors (defined as a cumulative vasopressor index = 4) to treat shock

Exclusion Criteria:

  1. Age <18 years;
  2. Pregnancy;
  3. Any primary diagnosis other than sepsis;
  4. Established Do Not Resuscitate status or advanced directives restricting aggressive care or treating physician deems aggressive care unsuitable;
  5. Known hyperkalemia (serum potassium >5.5);
  6. Dialysis-dependent renal failure;
  7. Anticipated requirement for immediate surgery (within 24 hours);
  8. Active participation in another interventional study;
  9. Transferred from another hospital setting with sepsis therapy initiated;
  10. Inability to obtain informed consent;
  11. Cardiopulmonary resuscitation (chest compression or defibrillation) prior to enrollment;
  12. Active malignancy currently under treatment (chemo- or radiation therapy);
  13. Known systemic allergy to insulin;
  14. History of periodic paralysis associated with carbohydrate loading;
  15. Receiving continuous intravenous inotropic support (including dobutamine, milrinone, amrinone, and levosimendan).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00823108

United States, North Carolina
Carolinas Medical Center
Charlotte, North Carolina, United States, 28203
Sponsors and Collaborators
Carolinas Healthcare System
Study Director: Alan E Jones, MD Carolinas Medical Center

Responsible Party: Alan E. Jones, MD, Carolinas Medical Center Identifier: NCT00823108     History of Changes
Other Study ID Numbers: 12-08-23B
First Posted: January 15, 2009    Key Record Dates
Last Update Posted: June 1, 2011
Last Verified: May 2011

Keywords provided by Carolinas Healthcare System:
GIK, septic shock, sepsis

Additional relevant MeSH terms:
Shock, Septic
Systemic Inflammatory Response Syndrome
Pathologic Processes
Hypoglycemic Agents
Physiological Effects of Drugs