THE IMPACT OF HIGH VERSUS STANDARD ENTERAL PROTEIN PROVISION ON FUNCTIONAL RECOVERY FOLLOWING INTENSIVE CARE ADMISSION: A RANDOMIZED CONTROLLED, MULTICENTER, PARALLEL GROUP TRIAL IN MECHANICALLY VENTILATED, CRITICALLY ILL PATIENTS

THE IMPACT OF HIGH VERSUS STANDARD ENTERAL PROTEIN PROVISION ON FUNCTIONAL RECOVERY FOLLOWING INTENSIVE CARE ADMISSION: A RANDOMIZED CONTROLLED, MULTICENTER, PARALLEL GROUP TRIAL IN MECHANICALLY VENTILATED, CRITICALLY ILL PATIENTS - PRotEin provision in Critical IllneSs (PRECISe)

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON52851

Enrollment

515

Registered

2020-10-05

Start date

2020-11-19

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critical illness (aandoening die IC opname nodig maakt) Critical illness IC admission

Interventions

comparing two isocaloric, isovolumetric enteral feeds with either - a standard (5g protein/100 kcal) or - a high (8g protein/100 kcal) protein content

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: * Adult (>= 18 years) patient admitted to the ICU * Unplanned ICU admission * Invasive mechanical ventilation initiated = 3 days

Exclusion criteria

Exclusion criteria: * Contraindication for enteral nutrition at the discretion of the treating physician * Moribund or expected withholding of treatment * Kidney failure and *no dialysis*-code on admission * Hepatic encephalopathy (West Haven criteria 3-4) * Body mass index

Design outcomes

Primary

Measure	Time frame
Overall between group-differences in health Related Quality of Life (HRQL) at 30 days, 90 days and 180 days after index ICU admission, assessed by EuroQoL (EQ-5D-5L).	—

Secondary

Measure	Time frame
Established Core Outcome Measures Set developed by an international expert panel using Delphi consensus methods: • Overall survival • Changes in health-related quality of life, as assessed by Short Form 36 (SF-36) questionnaire, completed at 30 days, 90 days and 180 days after ICU admission • Changes in the mental health status, assessed by the Hospital Anxiety and Depression Scale (HADS) EQ-VAS of the EQ-5D-5L and IES-R Impact of Event Scale, all completed at 30 days, 90 days and 180 days after ICU admission • Changes in the pain level, assessed by the pain question of the EQ-5D-5L questionnaire, completed at 30 days, 90 days and 180 days after ICU admission • Changes in physical function, as assessed by the 6-minute walk test performed at 30 days, 90 days and 180 days after ICU admission • Changes in muscle and nerve function, as assessed by the MRC-SUM score and Handgrip strength (Dynamometer), performed at 30 days, 90 days and 180 days after ICU admission	—

Measure

Time frame

Established Core Outcome Measures Set developed by an international expert panel using Delphi consensus methods: • Overall survival • Changes in health-related quality of life, as assessed by Short Form 36 (SF-36) questionnaire, completed at 30 days, 90 days and 180 days after ICU admission • Changes in the mental health status, assessed by the Hospital Anxiety and Depression Scale (HADS) EQ-VAS of the EQ-5D-5L and IES-R Impact of Event Scale, all completed at 30 days, 90 days and 180 days after ICU admission • Changes in the pain level, assessed by the pain question of the EQ-5D-5L questionnaire, completed at 30 days, 90 days and 180 days after ICU admission • Changes in physical function, as assessed by the 6-minute walk test performed at 30 days, 90 days and 180 days after ICU admission • Changes in muscle and nerve function, as assessed by the MRC-SUM score and Handgrip strength (Dynamometer), performed at 30 days, 90 days and 180 days after ICU admission

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)