Rapid Administration of Insulin in Sepsis

Septic Shock Clinical Trial

Official title:

Rapid Administration of Insulin in Sepsis: A Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00823108
• Other study ID #: 12-08-23B
• Status: Completed
• Phase: Phase 1
• Start date: March 2009
• Est. completion date: October 2010

Study information

• Verified date: May 2011
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Sepsis
• Septic Shock
• Shock, Septic

Intervention

Drug:
• GIK
12 hour infusion of GIK solution

Locations

Country	Name	City	State
United States	Carolinas Medical Center	Charlotte	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Absolute safety endpoint (explicit definitions)		During infusion
Primary	Change in SOFA score, microcirculatory flow		During infusion