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OpenTrials
Completed

NCT Number: NCT00823108

Rapid Administration of Insulin in Sepsis

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Carolinas Medical Center

Charlotte, North Carolina, 28203, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

GIK

Drug

12 hour infusion of GIK solution

Primary outcomes

  1. Absolute safety endpoint (explicit definitions)

    Time frame: During infusion

  2. Change in SOFA score, microcirculatory flow

    Time frame: During infusion

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Registry information

Official study title

Rapid Administration of Insulin in Sepsis: A Pilot Study

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jan 15, 2009
Registry last updated
Apr 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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