Systemic Inflammatory Response SyndromeNCT00893932
Leptin: a Therapeutic Option for Treating Catabolic States and Malnutrition in Critically Ill Patients
An observational study of Systemic Inflammatory Response Syndrome, run by Hadassah Medical Organization at 1 site in Israel.
Trial summary
Leptin is a hormone that plays a central role in food intake and energy balance. It is secreted by fat cells, released into the circulation and transported into the central nervous system (brain), where it regulates energy balance and food intake. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Systemic Inflammatory Response Syndrome
- How many people
- 75 participants
- Where
- 1 siteIsrael
- Study dates
- Aug 2008to Dec 2009
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients admitted to the Medical ICU and diagnosed with SIRS
Who may be able to join
None listed.
Who cannot join
- Patients under 18, pregnant patients, patients who refuse to participate
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Medical ICU, Hadassah Medical Organization
Jerusalem, 91120
Sigal Sviri, MD, 972 2 6777111, sigals@hadassah.org.il
Yosepha Avraham, pHD, 972 2 6757547
About this study
Leptin is a hormone that plays a central role in food intake and energy balance. It is secreted by fat cells, released into the circulation and transported into the central nervous system (brain), where it regulates energy balance and food intake. The overall effects of leptin appear to reduce food intake when the body is calorically satisfied, and to alter metabolic rate A decrease in the amount of body fat, which occurs after fasting, reduces the level of leptin, thereby stimulating food intake. Systemic Inflammation is a condition in which body tissues respond to stress. It may be associated with severe infection or other stimuli such as trauma, and may lead to organ failure and death. It has been shown, that Leptin may be a "survival protein", where higher levels are associated with lower mortality. The investigators set out to quantify the levels of Leptin in critically ill patients in association with other markers of inflammation and mortality.
Read the detailed description
Patients admitted to the Medical Intensive Care Unit who comply with criteria for SIRS (Systemic inflammatory response syndrome) will be enrolled into the study.
SIRS can be diagnosed when two or more of the following are present:
- Heart rate > 90 beats per minute
- Body temperature < 36 or > 38°C
- Hyperventilation (high respiratory rate) > 20 breaths per minute or, on blood gas, a PaCO2 < 32 mm Hg or mechanically ventilated
- White blood cell count < 4000 cells/mm3 or > 12000 cells/mm3 (< 4 x 109 or > 12 x 109 cells/L), or the presence of greater than 10% immature neutrophils.
Clinical parameters will be collected including: demographics, diagnosis, past medical history, past and present medications, fluids and nutrition administered, oxygenation and ventilation parameters, hemodynamic status and renal function and/or replacement therapy. Severity of illness using APACHE II score, major events during unit stay such as procedures, length of inotropic support, complications. Length of unit and hospital stay, length of ventilation, unit and hospital outcome.
Baseline leptin levels (within 8 hours of admission) will be obtained. Subsequent levels of leptin will be measured every 2 days or until discharge from the unit or death.
Serial blood count, chemistry, total protein, albumin, renal and liver function, glucose and insulin levels, lactate, total cholesterol, TSH, T3, IL-6, TNF-a, adiponectin, CRP, ESR, urine output, creatinine clearance and Nitrogen balance will be obtained.
- Conditions
- Systemic Inflammatory Response Syndrome
- Keywords
- SIRS leptin outcome sepsis
- Medical subject headings
- Systemic Inflammatory Response Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| SIRS | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess in the intensive care setting leptin levels and their relationship to inflammatory cytokines during the course of catabolic illnesses and following recovery.
Measured: 14 days, discharge from ICU or death
Secondary outcomes (1)
To measure indices of metabolism, catabolism and ICU outcome and their associations with leptin response.
Measured: 14 days, ICU discharge or death
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2009 (estimated)
- Study startAug 2008
- Primary completionAug 2009 (estimated)
- Study completionDec 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Inflammatory Response SyndromeStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Collaborators
- Hebrew University of Jerusalem
- Investigators
- Sigal Sviri, MD, Principal investigator, Hadassah Medical OrganizationYosepha Avraham, pHD, Principal investigator, Hebrew University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00893932
- Sponsor's protocol ID
- LeptinHadassahMO
- Status last verified
- Apr 2009
- First submitted
- 5 May 2009
- Last updated
- 6 May 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Leptin: a Therapeutic Option for Treating Catabolic States and Malnutrition in Critically Ill Patients
- ClinicalTrials.gov ID
- NCT00893932
- Acronym / sponsor ID
- LeptinHadassahMO
- Conditions
- Systemic Inflammatory Response Syndrome
- Keywords
- SIRS leptin outcome sepsis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Collaborators
- Hebrew University of Jerusalem
- Study start
- Aug 2008
- Primary completion
- Aug 2009 (estimated)
- Study completion
- Dec 2009 (estimated)
- First posted
- 6 May 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.
Leptin is a hormone that plays a central role in food intake and energy balance. It is secreted by fat cells, released into the circulation and transported into the central nervous system (brain), where it regulates energy balance and food intake. The overall effects of leptin appear to reduce food intake when the body is calorically satisfied, and to alter metabolic rate A decrease in the amount of body fat, which occurs after fasting, reduces the level of leptin, thereby stimulating food intake. Systemic Inflammation is a condition in which body tissues respond to stress. It may be associated with severe infection or other stimuli such as trauma, and may lead to organ failure and death. It has been shown, that Leptin may be a "survival protein", where higher levels are associated with lower mortality. The investigators set out to quantify the levels of Leptin in critically ill patients in association with other markers of inflammation and mortality.
Detailed description
Patients admitted to the Medical Intensive Care Unit who comply with criteria for SIRS (Systemic inflammatory response syndrome) will be enrolled into the study.
SIRS can be diagnosed when two or more of the following are present:
- Heart rate > 90 beats per minute
- Body temperature < 36 or > 38°C
- Hyperventilation (high respiratory rate) > 20 breaths per minute or, on blood gas, a PaCO2 < 32 mm Hg or mechanically ventilated
- White blood cell count < 4000 cells/mm3 or > 12000 cells/mm3 (< 4 x 109 or > 12 x 109 cells/L), or the presence of greater than 10% immature neutrophils.
Clinical parameters will be collected including: demographics, diagnosis, past medical history, past and present medications, fluids and nutrition administered, oxygenation and ventilation parameters, hemodynamic status and renal function and/or replacement therapy. Severity of illness using APACHE II score, major events during unit stay such as procedures, length of inotropic support, complications. Length of unit and hospital stay, length of ventilation, unit and hospital outcome.
Baseline leptin levels (within 8 hours of admission) will be obtained. Subsequent levels of leptin will be measured every 2 days or until discharge from the unit or death.
Serial blood count, chemistry, total protein, albumin, renal and liver function, glucose and insulin levels, lactate, total cholesterol, TSH, T3, IL-6, TNF-a, adiponectin, CRP, ESR, urine output, creatinine clearance and Nitrogen balance will be obtained.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SIRS | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to the Medical ICU and diagnosed with SIRS
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- Patients under 18, pregnant patients, patients who refuse to participate
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
To assess in the intensive care setting leptin levels and their relationship to inflammatory cytokines during the course of catabolic illnesses and following recovery.
Time frame: 14 days, discharge from ICU or death
1 secondary outcome
To measure indices of metabolism, catabolism and ICU outcome and their associations with leptin response.
Time frame: 14 days, ICU discharge or death
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2009.
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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.
Sigal Sviri, MD principal investigator
Hadassah Medical Organization
Yosepha Avraham, pHD principal investigator
Hebrew University
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 Systemic Inflammatory Response Syndrome, run by Hadassah Medical Organization 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?
The sponsor lists 0 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 6 May 2009. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess in the intensive care setting leptin levels and their relationship to inflammatory cytokines during the course of catabolic illnesses and following recovery. (time frame: 14 days, discharge from ICU or death). 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 6 May 2009.