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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2009 by Hadassah Medical Organization.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Hebrew University of Jerusalem
Information provided by:
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT00893932
First received: May 5, 2009
Last updated: NA
Last verified: April 2009
History: No changes posted
  Purpose

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
Systemic Inflammatory Response Syndrome

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To measure indices of metabolism, catabolism and ICU outcome and their associations with leptin response. [ Time Frame: 14 days, ICU discharge or death ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Blood samples for leptin levels


Estimated Enrollment: 75
Study Start Date: August 2008
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Sigal Sviri MD, Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT00893932     History of Changes
Other Study ID Numbers: LeptinHadassahMO
Study First Received: May 5, 2009
Last Updated: May 5, 2009
Health Authority: Israel: Ministry of Health

Keywords provided by Hadassah Medical Organization:
SIRS leptin outcome sepsis

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

ClinicalTrials.gov processed this record on August 26, 2014