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Leptin: a Therapeutic Option for Treating Catabolic States and Malnutrition in Critically Ill Patients

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ClinicalTrials.gov Identifier: NCT00893932
Recruitment Status : Unknown
Verified April 2009 by Hadassah Medical Organization.
Recruitment status was:  Recruiting
First Posted : May 6, 2009
Last Update Posted : May 6, 2009
Sponsor:
Collaborator:
Hebrew University of Jerusalem
Information provided by:
Hadassah Medical Organization

Brief 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. 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.

Condition or disease
Systemic Inflammatory Response Syndrome

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 Type : Observational
Estimated Enrollment : 75 participants
Observational Model: Cohort
Time Perspective: Prospective
Study Start Date : August 2008
Estimated Primary Completion Date : August 2009
Estimated Study Completion Date : December 2009

Group/Cohort
SIRS



Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. To measure indices of metabolism, catabolism and ICU outcome and their associations with leptin response. [ Time Frame: 14 days, ICU discharge or death ]

Biospecimen Retention:   Samples Without DNA
Blood samples for leptin levels


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients admitted to the Medical ICU and diagnosed with SIRS
Criteria

Inclusion Criteria:All patients with Systemic Inflammatory Response Syndrome (SIRS).

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.

Exclusion Criteria:

  • Patients under 18, pregnant patients, patients who refuse to participate

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00893932


Locations
Israel
Medical ICU, Hadassah Medical Organization Recruiting
Jerusalem, Israel, 91120
Contact: Sigal Sviri, MD    972 2 6777111    sigals@hadassah.org.il   
Contact: Yosepha Avraham, pHD    972 2 6757547      
Principal Investigator: Sigal Sviri, MD         
Principal Investigator: Yosepha Avraham, PHD         
Principal Investigator: Elliot Beeri, MD         
Principal Investigator: Zipora Neuman, MD         
Sub-Investigator: Abed Bayya, MD         
Sub-Investigator: Ilana Stav         
Sponsors and Collaborators
Hadassah Medical Organization
Hebrew University of Jerusalem
Investigators
Principal Investigator: Sigal Sviri, MD Hadassah Medical Organization
Principal Investigator: Yosepha Avraham, pHD Hebrew University

Responsible Party: Sigal Sviri MD, Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT00893932     History of Changes
Other Study ID Numbers: LeptinHadassahMO
First Posted: May 6, 2009    Key Record Dates
Last Update Posted: May 6, 2009
Last Verified: April 2009

Keywords provided by Hadassah Medical Organization:
SIRS leptin outcome sepsis

Additional relevant MeSH terms:
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Shock