Rapid Administration of Insulin in Sepsis

This study has been completed.
Sponsor:
Information provided by:
Carolinas Healthcare System
ClinicalTrials.gov Identifier:
NCT00823108
First received: January 14, 2009
Last updated: May 31, 2011
Last verified: May 2011
  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

Resource links provided by NLM:


Further study details as provided by Carolinas Healthcare System:

Primary Outcome Measures:
  • 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
Criteria

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00823108

Locations
United States, North Carolina
Carolinas Medical Center
Charlotte, North Carolina, United States, 28203
Sponsors and Collaborators
Carolinas Healthcare System
Investigators
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 July 29, 2014