Leptin and Ghrelin in ICU

NCT02282501 | Completed Phase 4

• 1 other identifier: Odu-4
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Critically Ill

Keywords

leptin levels; ghrelin levels

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

intermittent feeding

ACTIVE COMPARATOR

Bolus infusion - The total daily feeding period was also 4-6 times a day.

Other: enteral feeding by nasogastric tube.

continuous feeding

ACTIVE COMPARATOR

Continuous infusion - The daily desired amount was offered continuously for 20 hours a day.

Other: enteral feeding by nasogastric tube.

Interventions

enteral feeding by nasogastric tube. OTHER

method of administration enteral feeding by nasogastric tube.

continuous feeding; intermittent feeding

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• who were unable to ingest an oral diet
• given decision on enteral feeding

You may not qualify if:

• 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

Sponsors & Collaborators

• özgür yağan: lead

Study Sites (1)

Anesthesiology and Reanimation Dept. Ordu University Training and Research Hospital

Altinordu, Ordu, 52100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, assistant professor

Study Record Dates

• First Submitted: October 30, 2014
• First Posted: November 4, 2014
• Study Start: August 1, 2014
• Primary Completion: October 1, 2015
• Study Completion: February 1, 2016
• Last Updated: March 29, 2016

Record last verified: 2016-03

Locations

TU (1)