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Rapid Administration of Insulin in Sepsis

Sponsor
Wake Forest University Health Sciences (Other)
Overall Status
Completed
CT.gov ID
NCT00823108
Collaborator
(none)
20
Enrollment
1
Location
2
Arms
19
Duration (Months)
1.1
Patients Per Site Per Month

Study Details

Study Description

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
Phase 1

Study Design

Study Type:
Interventional
Anticipated 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 :
Mar 1, 2009
Actual Primary Completion Date :
Oct 1, 2010
Actual Study Completion Date :
Oct 1, 2010

Arms and Interventions

Arm Intervention/Treatment
Experimental: 1

Glucose-insulin-potassium

Drug: GIK
12 hour infusion of GIK solution
No Intervention: 2

Control

Outcome Measures

Primary Outcome Measures

  1. Absolute safety endpoint (explicit definitions) [During infusion]

  2. Change in SOFA score, microcirculatory flow [During infusion]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
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

  1. Initiation of quantitative resuscitation protocol in the ED;

  2. 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).

Contacts and Locations

Locations

Site City State Country Postal Code
1 Carolinas Medical Center Charlotte North Carolina United States 28203

Sponsors and Collaborators

  • Wake Forest University Health Sciences

Investigators

  • Study Director: Alan E Jones, MD, Carolinas Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Wake Forest University Health Sciences
ClinicalTrials.gov Identifier:
NCT00823108
Other Study ID Numbers:
  • 12-08-23B
First Posted:
Jan 15, 2009
Last Update Posted:
Apr 25, 2022
Last Verified:
May 1, 2011
Keywords provided by Wake Forest University Health Sciences
GIK, septic shock, sepsis
Additional relevant MeSH terms:
Sepsis
Shock, Septic

Study Results

No Results Posted as of Apr 25, 2022