Rapid Administration of Insulin in Sepsis

Rapid Administration of Insulin in Sepsis: A Pilot Study

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.

Study Overview

• Status: Completed
• Conditions: Septic Shock
• Intervention / Treatment: Drug: GIK

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Charlotte, North Carolina, United States, 28203
      • Carolinas Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; Glucose-insulin-potassium	Drug: GIK; 12 hour infusion of GIK solution
No Intervention: 2; Control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Absolute safety endpoint (explicit definitions)	During infusion
Change in SOFA score, microcirculatory flow	During infusion

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Investigators: Study Director: Alan E Jones, MD, Carolinas Medical Center

Study record dates

Study Major Dates

• Study Start: March 1, 2009
• Primary Completion (Actual): October 1, 2010
• Study Completion (Actual): October 1, 2010

Study Registration Dates

• First Submitted: January 14, 2009
• First Submitted That Met QC Criteria: January 14, 2009
• First Posted (Estimate): January 15, 2009

Study Record Updates

• Last Update Posted (Actual): April 25, 2022
• Last Update Submitted That Met QC Criteria: April 19, 2022
• Last Verified: May 1, 2011

More Information

Terms related to this study

• Keywords: GIK, septic shock, sepsis
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Shock; Sepsis; Shock, Septic
• Other Study ID Numbers: 12-08-23B