Leptin and Ghrelin in ICU

March 28, 2016 updated by: özgür yağan

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Ordu
      • Altınordu, Ordu, Turkey, 52100
        • Anesthesiology and Reanimation Dept. Ordu University Training and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: intermittent feeding
Bolus infusion - The total daily feeding period was also 4-6 times a day.
Other: enteral feeding by nasogastric tube.
method of administration enteral feeding by nasogastric tube.
Active Comparator: continuous feeding
Continuous infusion - The daily desired amount was offered continuously for 20 hours a day.
Other: enteral feeding by nasogastric tube.
method of administration enteral feeding by nasogastric tube.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in serum leptin concentration at three weeks in ICU
Time Frame: first, 7th, 14th and 21th day
first, 7th, 14th and 21th day
Change from baseline in serum ghrelin concentration at three weeks in ICU
Time Frame: first, 7th, 14th and 21th day in ICU
first, 7th, 14th and 21th day in ICU

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

özgür yağan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2014

Primary Completion (Actual)

October 1, 2015

Study Completion (Actual)

February 1, 2016

Study Registration Dates

First Submitted

October 30, 2014

First Submitted That Met QC Criteria

November 3, 2014

First Posted (Estimate)

November 4, 2014

Study Record Updates

Last Update Posted (Estimate)

March 29, 2016

Last Update Submitted That Met QC Criteria

March 28, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Odu-4

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Critically Ill

Clinical Trials on enteral feeding by nasogastric tube.

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Peru

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe