Effect of an anti-inflammatory formula for Oral Nutrition Support (ONS) in critically ill patients admitted to the intensive care unit

Phase 3

Recruiting

• Conditions: Condition 1: sepsis. Condition 2: Acute respiratory distress syndrome (ARDS). Condition 3: critically ill patients.

• Registration Number: IRCT20210217050393N4
• Lead Sponsor: Mashhad University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 21 August 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 74

Inclusion Criteria

Age 65-18 years
Normal Gastrointestinal function
Having indication for enteral nutrition

Exclusion Criteria

Impossibility of enteral feeding in the first 48 hours of admission
History of underlying advanced heart disease
Patients who are hospitalized in the intensive care unit for less than 96 hours.
Patients expected to die within 12 hours of admission to the intensive care unit.
Patients who do not have an indication for enteral nutrition on the first day, and based on the diagnosis of the intensive care unit, it is confirmed and predicted that they will not be able to receive enteral nutrition in the future.
Patients who are under nutritional support by complete Parenteral Nutrition.
Patients who have a history of underlying disease such as uncontrolled diabetes, congenital and immune disorders, advanced kidney and liver failure, and pancreatitis.
Lack of consent of the patients or their legal guardian

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
(hs-crp) Inflammatory factor. Timepoint: At baseline, day 7 and day 14. Method of measurement: ELISA kit.;ESR inflammatory factor. Timepoint: At baseline, day 7 and day 14. Method of measurement: ELISA kit.;TAC antioxidant factor. Timepoint: At baseline, day 7 and day 14. Method of measurement: ELISA kit.;MDA antioxidant factor. Timepoint: At baseline, day 7 and day 14. Method of measurement: ELISA kit.;SOFA disease severity measure. Timepoint: At baseline, day 7 and day 14. Method of measurement: SOFA score questionnaire.