- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00823108
Rapid Administration of Insulin in Sepsis
April 19, 2022 updated by: Wake Forest University Health Sciences
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
Study Type
Interventional
Enrollment (Anticipated)
20
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
North Carolina
-
Charlotte, North Carolina, United States, 28203
- Carolinas Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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:
- 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).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
Glucose-insulin-potassium
|
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)
Time Frame: During infusion
|
During infusion
|
Change in SOFA score, microcirculatory flow
Time Frame: During infusion
|
During infusion
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Alan E Jones, MD, Carolinas Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 12-08-23B
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Septic Shock
-
German Center for Neurodegenerative Diseases (DZNE)University Hospital, BonnUnknownSevere Sepsis With Septic Shock | Severe Sepsis Without Septic ShockGermany
-
McMaster UniversityCanadian Institutes of Health Research (CIHR); The Physicians' Services Incorporated...Recruiting
-
Assistance Publique - Hôpitaux de ParisCompletedSeptic Shock HyperdynamicFrance
-
National Taiwan University HospitalBaxter Healthcare CorporationRecruiting
-
Charite University, Berlin, GermanyCompleted
-
University of ZurichCompletedPatients in Septic ShockSwitzerland
-
University Medicine GreifswaldUnknownSepsis Septic ShockGermany
-
Indonesia UniversityCompletedSevere Sepsis With Septic Shock | Severe Sepsis Without Septic ShockIndonesia
-
Azienda Ospedaliero, Universitaria PisanaUnknown
-
University Hospital, GrenobleCompletedImmunocompetent Patient on Septic ShockFrance
Clinical Trials on GIK
-
Yonsei UniversityCompletedAcute Coronary SyndromeKorea, Republic of
-
American Heart AssociationCompletedGlycemic ControlUnited States
-
NYU Langone HealthNot yet recruitingFemoral Shaft Fracture | Tibial Shaft FractureUnited States
-
Yonsei UniversityCompletedEffect of Glucose-Insulin-Potassium on Hyperlactatemia in Patients Undergoing Valvular Heart SurgeryValvular Heart DiseaseKorea, Republic of
-
University of VirginiaNational Institute of Neurological Disorders and Stroke (NINDS)Completed
-
University of MonastirCompletedAcute Coronary SyndromeTunisia
-
Centre Hospitalier Universitaire VaudoisUnknownMyocardial InfarctionSwitzerland
-
Tufts Medical CenterNational Heart, Lung, and Blood Institute (NHLBI)CompletedMyocardial Infarction | Heart Diseases | Cardiovascular Diseases | Coronary Disease | Angina, Unstable | Heart Failure, CongestiveUnited States
-
Central South UniversityCompletedLiver TransplantationChina
-
Xijing HospitalUnknown