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

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.

Study Overview

• Status: Unknown
• Conditions: 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
• Enrollment (Anticipated): 75

Contacts and Locations

Study Locations

• Israel
  • Jerusalem, Israel, 91120
    • Recruiting
    • Medical ICU, Hadassah Medical Organization
    • Principal Investigator: Sigal Sviri, MD
    • Sub-Investigator: Abed Bayya, MD
    • Contact: Sigal Sviri, MD; Phone Number: 972 2 6777111; Email: sigals@hadassah.org.il
    • Contact: Yosepha Avraham, pHD; Phone Number: 972 2 6757547
    • Principal Investigator: Yosepha Avraham, PHD
    • Principal Investigator: Elliot Beeri, MD
    • Principal Investigator: Zipora Neuman, MD
    • Sub-Investigator: Ilana Stav

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients admitted to the Medical ICU and diagnosed with SIRS

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
SIRS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
To measure indices of metabolism, catabolism and ICU outcome and their associations with leptin response.	14 days, ICU discharge or death

Collaborators and Investigators

• Sponsor: Hadassah Medical Organization
• Collaborators: Hebrew University of Jerusalem
• Investigators: Principal Investigator: Sigal Sviri, MD, Hadassah Medical Organization; Principal Investigator: Yosepha Avraham, pHD, Hebrew University

Study record dates

Study Major Dates

• Study Start: August 1, 2008
• Primary Completion (Anticipated): August 1, 2009
• Study Completion (Anticipated): December 1, 2009

Study Registration Dates

• First Submitted: May 5, 2009
• First Submitted That Met QC Criteria: May 5, 2009
• First Posted (Estimate): May 6, 2009

Study Record Updates

• Last Update Posted (Estimate): May 6, 2009
• Last Update Submitted That Met QC Criteria: May 5, 2009
• Last Verified: April 1, 2009

More Information

Terms related to this study

• Keywords: SIRS leptin outcome sepsis
• Additional Relevant MeSH Terms: Pathologic Processes; Inflammation; Shock; Systemic Inflammatory Response Syndrome
• Other Study ID Numbers: LeptinHadassahMO