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Leptin and Ghrelin in ICU

Primary Purpose

Critically Ill

Status

Completed

Phase

Phase 4

Locations

Turkey

Study Type

Interventional

Intervention

enteral feeding by nasogastric tube.

About this trial

This is an interventional diagnostic trial for Critically Ill focused on measuring leptin levels, ghrelin levels

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Anesthesiology and Reanimation Dept. Ordu University Training and Research Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

intermittent feeding

continuous feeding

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change from baseline in serum leptin concentration at three weeks in ICU

Change from baseline in serum ghrelin concentration at three weeks in ICU

Secondary Outcome Measures

Full Information

NCT ID

NCT02282501

First Posted

October 30, 2014

Last Updated

March 28, 2016

Sponsor

özgür yağan

1. Study Identification

Unique Protocol Identification Number

NCT02282501

Brief Title

Leptin and Ghrelin in ICU

Study Type

Interventional

2. Study Status

Record Verification Date

March 2016

Overall Recruitment Status

Completed

Study Start Date

August 2014 (undefined)

Primary Completion Date

October 2015 (Actual)

Study Completion Date

February 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

özgür yağan

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Critically Ill

Keywords

leptin levels, ghrelin levels

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

intermittent feeding

Arm Type

Active Comparator

Arm Description

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

Arm Title

continuous feeding

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Other

Intervention Name(s)

enteral feeding by nasogastric tube.

Intervention Description

method of administration enteral feeding by nasogastric tube.

Primary Outcome Measure Information:

Title

Change from baseline in serum leptin concentration at three weeks in ICU

Time Frame

first, 7th, 14th and 21th day

Title

Change from baseline in serum ghrelin concentration at three weeks in ICU

Time Frame

first, 7th, 14th and 21th day in ICU

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Anesthesiology and Reanimation Dept. Ordu University Training and Research Hospital

City

Altınordu

State/Province

Ordu

ZIP/Postal Code

52100

Country

Turkey

12. IPD Sharing Statement

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