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

NCT00893932 | Unknown

• 1 other identifier: LeptinHadassahMO
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Systemic Inflammatory Response Syndrome

Keywords

SIRS leptin outcome sepsis

Outcome Measures

Primary Outcomes (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.

  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.

  14 days, ICU discharge or death

Study Arms (1)

SIRS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients admitted to the Medical ICU and diagnosed with SIRS

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Hadassah Medical Organization: lead
• Hebrew University of Jerusalem: collaborator

Study Sites (1)

Medical ICU, Hadassah Medical Organization

Jerusalem, 91120, Israel

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples for leptin levels

MeSH Terms

Conditions

Systemic Inflammatory Response Syndrome

Condition Hierarchy (Ancestors)

Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Study Officials

• Sigal Sviri, MD

  Hadassah Medical Organization

  PRINCIPAL INVESTIGATOR

• Yosepha Avraham, pHD

  Hebrew University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 5, 2009
• First Posted: May 6, 2009
• Study Start: August 1, 2008
• Primary Completion: August 1, 2009
• Study Completion: December 1, 2009
• Last Updated: May 6, 2009

Record last verified: 2009-04

Locations

IL (1)