Leptin and Ghrelin in ICU

Phase 4

Completed

• Conditions: Critically Ill
• Interventions: Other: enteral feeding by nasogastric tube.

• Registration Number: NCT02282501
• Lead Sponsor: özgür yağan

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-08
• Study First Submitted: 2014-10-30
• Study First Submitted QC: 2014-11-03
• Study First Posted: 2014-11-04
• Primary Completion: 2015-10
• Study Completion: 2016-02
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-28
• Last Update Posted: 2016-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
intermittent feeding	enteral feeding by nasogastric tube.	Bolus infusion - The total daily feeding period was also 4-6 times a day.
continuous feeding	enteral feeding by nasogastric tube.	Continuous infusion - The daily desired amount was offered continuously for 20 hours a day.

Primary Outcome Measures

Name	Time	Method
Change from baseline in serum leptin concentration at three weeks in ICU	first, 7th, 14th and 21th day
Change from baseline in serum ghrelin concentration at three weeks in ICU	first, 7th, 14th and 21th day in ICU

Trial Locations

Locations (1)

Anesthesiology and Reanimation Dept. Ordu University Training and Research Hospital; 🇹🇷 Altınordu, Ordu, Turkey