Acquired ICU BacteremiaNCT04992689
Increasing Insulin Resistance as a Predictor of Impending Bacteremia
An observational study of Acquired ICU Bacteremia, run by Meir Medical Center at 1 site in Israel.
Trial summary
Insulin resistance is defined as a decrease in the ability of insulin to lower blood glucose levels. Various pathological conditions can cause an increase in insulin resistance, such as sepsis, administration of certain medications, various stressful situations, surgery or significant injuries, etc. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Acquired ICU Bacteremia
- How many people
- 113 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Dec 2021to 1 Jan 2024
- Phase
- Observational
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with acquired ICU bacteremia
Inclusion Criteria:Patients aged 18-100, diabetic and non-diabetic, admitted to the General Intensive Care Unit from January 2013 to January 2021 (inclusive) for any reason, required during their hospitalization a continuous infusion of insulin, and developed during their hospitalization acquired bacteremia after more than 48 hours from ICU admission.
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Exclusion Criteria:Patients who did not receive a continuous insulin infusion, patients with bacteremia of non-pathogenic bacteria (contamination), patients who developed bacteremia less than 48 hours after ICU admission, patients who received drugs that might influence insulin resistance (steroids, glucagon) or patients with other reasons that might explain an increase in insulin resistance other than infection.
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Trial locations and contacts
1 site in 1 country.
About this study
Official title: Increasing Insulin Resistance as a Predictor of Impending Bacteremia: A Retrospective Study
Insulin resistance is defined as a decrease in the ability of insulin to lower blood glucose levels. Various pathological conditions can cause an increase in insulin resistance, such as sepsis, administration of certain medications, various stressful situations, surgery or significant injuries, etc. Sepsis can cause extreme stress, which causes significant changes in metabolism, disruption of blood glucose regulation and increased insulin resistance. In sepsis there is an extreme activation of inflammatory mediators and of counter-regulatory hormones, such as cortisol, glucagon and catecholamines, which increase hepatic gluconeogenesis on the one hand, and increase the peripheral resistance to insulin on the other hand.
Disorder in the regulation of blood glucose level causes increased mortality and morbidity among intensive care unit patients with sepsis, as well as an increase in the duration of hospitalization and its financial expenses.
Read more
There are a number of parameters used in the intensive care unit to diagnose the development of sepsis within the unit, such as an increase or decrease in body temperature, an increase in CRP level, white blood cell count, pro-calcitonin level, etc It is possible that an increase in insulin resistance can also be used as a predictor of sepsis. It should be noted that almost all patients hospitalized in the intensive care unit are treated with a continuous infusion of insulin to balance their blood glucose level, including patients who are not diagnosed with diabetes prior to their hospitalization in the unit. This is in light of the increase in insulin resistance for the reasons listed above among patients in critical condition, and also due to the need to maintain blood glucose values in the range of 140-180 mg/dl, since high blood glucose values among patients hospitalized in the intensive care unit are associated with increased morbidity and mortality.
We would therefore like to investigate whether an increase in insulin resistance, as expressed in an increase in the patient's insulin intake, can predict the development of sepsis secondary to bacteremia in the intensive care unit.
- Conditions
- Acquired ICU Bacteremia
- Keywords
- acquired bacteremia, insulin resistance
- Medical subject headings
- Insulin Resistance
What is being measured
The primary outcome is the main question the study is designed to answer.
Increased insulin resistance as a predictor of impending ICU acquired bacteremia
To establish a possible connection between increasing insulin resistance, as measured by changes in insulin infusion rate (units per hour) in order to maintain blood glucose level between 140-180 mg%, and development of acquired ICU bacteremia (at least 48 hours post ICU admission)
Measured: 6 months post ICU admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2021
- Study start1 Dec 2021
- Primary completion1 Jan 2024
- Study completion1 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acquired ICU BacteremiaStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, sara dichtwald, Meir Medical Center
- Investigators
- Sara Dichtwald, Dr, Principal investigator, Meir Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04992689
- Sponsor's protocol ID
- 0132-21-MMC
- Status last verified
- Mar 2024
- First submitted
- 25 Jul 2021
- Last updated
- 15 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increasing Insulin Resistance as a Predictor of Impending Bacteremia: A Retrospective Study
- ClinicalTrials.gov ID
- NCT04992689
- Acronym / sponsor ID
- 0132-21-MMC
- Conditions
- Acquired ICU Bacteremia
- Keywords
- acquired bacteremia, insulin resistance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 1 Jan 2024 (actual)
- Study completion
- 1 Jan 2024 (actual)
- First posted
- 5 Aug 2021 (actual)
- 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.
Insulin resistance is defined as a decrease in the ability of insulin to lower blood glucose levels. Various pathological conditions can cause an increase in insulin resistance, such as sepsis, administration of certain medications, various stressful situations, surgery or significant injuries, etc. Sepsis can cause extreme stress, which causes significant changes in metabolism, disruption of blood glucose regulation and increased insulin resistance. In sepsis there is an extreme activation of inflammatory mediators and of counter-regulatory hormones, such as cortisol, glucagon and catecholamines, which increase hepatic gluconeogenesis on the one hand, and increase the peripheral resistance to insulin on the other hand.
Disorder in the regulation of blood glucose level causes increased mortality and morbidity among intensive care unit patients with sepsis, as well as an increase in the duration of hospitalization and its financial expenses.
There are a number of parameters used in the intensive care unit to diagnose the development of sepsis within the unit, such as an increase or decrease in body temperature, an increase in CRP level, white blood cell count, pro-calcitonin level, etc It is possible that an increase in insulin resistance can also be used as a predictor of sepsis. It should be noted that almost all patients hospitalized in the intensive care unit are treated with a continuous infusion of insulin to balance their blood glucose level, including patients who are not diagnosed with diabetes prior to their hospitalization in the unit. This is in light of the increase in insulin resistance for the reasons listed above among patients in critical condition, and also due to the need to maintain blood glucose values in the range of 140-180 mg/dl, since high blood glucose values among patients hospitalized in the intensive care unit are associated with increased morbidity and mortality.
We would therefore like to investigate whether an increase in insulin resistance, as expressed in an increase in the patient's insulin intake, can predict the development of sepsis secondary to bacteremia in the intensive care unit.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with acquired ICU bacteremia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Increased insulin resistance as a predictor of impending ICU acquired bacteremia
Time frame: 6 months post ICU admission
To establish a possible connection between increasing insulin resistance, as measured by changes in insulin infusion rate (units per hour) in order to maintain blood glucose level between 140-180 mg%, and development of acquired ICU bacteremia (at least 48 hours post ICU admission)
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 15 Mar 2024.
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.
Sara Dichtwald, Dr principal investigator
Meir Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acquired ICU Bacteremia, run by Meir Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 15 Mar 2024. 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 Israel. 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.
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?
Increased insulin resistance as a predictor of impending ICU acquired bacteremia (time frame: 6 months post ICU admission). 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 15 Mar 2024.