Rapid Administration of Insulin in Sepsis

NCT00823108 | Completed Phase 1 DMC

• 1 other identifier: 12-08-23B
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Septic Shock

Keywords

GIK, septic shock, sepsis

Outcome Measures

Primary Outcomes (2)

• Absolute safety endpoint (explicit definitions)

  During infusion

• Change in SOFA score, microcirculatory flow

  During infusion

Study Arms (2)

1

EXPERIMENTAL

Glucose-insulin-potassium

Drug: GIK

2

NO INTERVENTION

Control

Interventions

GIK DRUG

12 hour infusion of GIK solution

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Carolinas Medical Center

Charlotte, North Carolina, 28203, United States

Location

MeSH Terms

Conditions

Shock, Septic; Sepsis

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Study Officials

• Alan E Jones, MD

  Carolinas Medical Center

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2009
• First Posted: January 15, 2009
• Study Start: March 1, 2009
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: April 25, 2022

Record last verified: 2011-05

Locations

US (1)