Leptin and Ghrelin in ICU

Critically Ill Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02282501
• Other study ID #: Odu-4
• Status: Completed
• Phase: Phase 4
• First received: October 30, 2014
• Last updated: March 28, 2016
• Start date: August 2014
• Est. completion date: February 2016

Study information

• Verified date: March 2016
• Source: T.C. ORDU ÜNIVERSITESI
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

Enteral alimentation is the preferred modality of support in critical patients who have acceptable digestive function and are unable to eat orally, but the advantages of continuous versus intermittent administration are surrounded by controversy.

This prospective, randomised study was designed to compare two enteral feeding methods with respect to changes in levels of leptin and ghrelin in ICU.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: February 2016
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• who were unable to ingest an oral diet

• given decision on enteral feeding

Exclusion Criteria:

• Carcinomatosis

• irreversible coma

• death or discharge before 14 days of observation

• contraindication to enteral feeding

• intolerance to the prescribed nutrients or infusion regimen

• burn

• multiple trauma

• morbid obesity

• end stage liver or renal or lung disease

• severe sepsis or septic shock

• patients with percutaneous endoscopic gastrostomy

• immunosuppressive drug use

• severe hemodynamic instability

• massive blood transfusion

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Critical Illness
• Critically Ill

Intervention

Other:
• enteral feeding by nasogastric tube.
method of administration enteral feeding by nasogastric tube.

Locations

Country	Name	City	State
Turkey	Anesthesiology and Reanimation Dept. Ordu University Training and Research Hospital	Altinordu	Ordu

Sponsors (1)

Lead Sponsor	Collaborator
özgür yagan

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in serum leptin concentration at three weeks in ICU		first, 7th, 14th and 21th day	No
Primary	Change from baseline in serum ghrelin concentration at three weeks in ICU		first, 7th, 14th and 21th day in ICU	No