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Rapid Administration of Insulin in Sepsis

Primary Purpose

Septic Shock

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
GIK
Sponsored by
Wake Forest University Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Septic Shock focused on measuring GIK, septic shock, sepsis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Carolinas Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

1

2

Arm Description

Glucose-insulin-potassium

Control

Outcomes

Primary Outcome Measures

Absolute safety endpoint (explicit definitions)
Change in SOFA score, microcirculatory flow

Secondary Outcome Measures

Full Information

First Posted
January 14, 2009
Last Updated
April 19, 2022
Sponsor
Wake Forest University Health Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT00823108
Brief Title
Rapid Administration of Insulin in Sepsis
Official Title
Rapid Administration of Insulin in Sepsis: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2011
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
October 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Septic Shock
Keywords
GIK, septic shock, sepsis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Glucose-insulin-potassium
Arm Title
2
Arm Type
No Intervention
Arm Description
Control
Intervention Type
Drug
Intervention Name(s)
GIK
Intervention Description
12 hour infusion of GIK solution
Primary Outcome Measure Information:
Title
Absolute safety endpoint (explicit definitions)
Time Frame
During infusion
Title
Change in SOFA score, microcirculatory flow
Time Frame
During infusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Suspected or confirmed infection; 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 Initiation of quantitative resuscitation protocol in the ED; Requirement of high dose vasopressors (defined as a cumulative vasopressor index = 4) to treat shock Exclusion Criteria: Age <18 years; Pregnancy; Any primary diagnosis other than sepsis; Established Do Not Resuscitate status or advanced directives restricting aggressive care or treating physician deems aggressive care unsuitable; Known hyperkalemia (serum potassium >5.5); Dialysis-dependent renal failure; Anticipated requirement for immediate surgery (within 24 hours); Active participation in another interventional study; Transferred from another hospital setting with sepsis therapy initiated; Inability to obtain informed consent; Cardiopulmonary resuscitation (chest compression or defibrillation) prior to enrollment; Active malignancy currently under treatment (chemo- or radiation therapy); Known systemic allergy to insulin; History of periodic paralysis associated with carbohydrate loading; Receiving continuous intravenous inotropic support (including dobutamine, milrinone, amrinone, and levosimendan).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alan E Jones, MD
Organizational Affiliation
Carolinas Medical Center
Official's Role
Study Director
Facility Information:
Facility Name
Carolinas Medical Center
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28203
Country
United States

12. IPD Sharing Statement

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Rapid Administration of Insulin in Sepsis

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