Septic ShockPhase 1NCT00823108
Rapid Administration of Insulin in Sepsis
A Phase 1 study testing GIK in people with Septic Shock, run by Wake Forest University Health Sciences at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Septic Shock
- What is being tested?
- GIK
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2009to Oct 2010
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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;
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- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
Carolinas Medical Center
Charlotte, North Carolina, 28203
About this study
Official title: 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.
- Conditions
- Septic Shock
- Being tested
- GIK
- Keywords
- GIK, septic shock, sepsis
- Medical subject headings
- Shock, Septic, Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GIKDrug
12 hour infusion of GIK solution
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Glucose-insulin-potassium Receives: Drug: GIK |
| 2 | No intervention | Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute safety endpoint (explicit definitions)
Measured: During infusion
Change in SOFA score, microcirculatory flow
Measured: During infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2009 (estimated)
- Study startMar 2009
- Primary completionOct 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Septic ShockStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alan E Jones, MD, Study director, Carolinas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00823108
- Sponsor's protocol ID
- 12-08-23B
- Status last verified
- May 2011
- First submitted
- 14 Jan 2009
- Last updated
- 25 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rapid Administration of Insulin in Sepsis: A Pilot Study
- ClinicalTrials.gov ID
- NCT00823108
- Acronym / sponsor ID
- 12-08-23B
- Conditions
- Septic Shock
- Keywords
- GIK, septic shock, sepsis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 15 Jan 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: GIKGlucose-insulin-potassium |
| 2 | No intervention | –Control |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Suspected or confirmed infection;
- Any two of four criteria of systemic inflammatory response:
- Initiation of quantitative resuscitation protocol in the ED;
- Requirement of high dose vasopressors (defined as a cumulative vasopressor index = 4) to treat shock
Key exclusion criteria (15 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GIK12 hour infusion of GIK solution | Drug | 1 |
Primary outcome
Absolute safety endpoint (explicit definitions)
Time frame: During infusion
Change in SOFA score, microcirculatory flow
Time frame: During infusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2022.
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ICU-SUCCEED for Survivors of Acute Respiratory Failure and Their Caregivers
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Longitudinal Trajectories of Myocardial Work in Patients With Sepsis
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Sepsis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alan E Jones, MD study director
Carolinas Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GIK in people with Septic Shock, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Absolute safety endpoint (explicit definitions) (time frame: During infusion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2022.