Investigating Nutrition and Functional Outcome in Critically Ill Patients

NCT ID: NCT04180852

Last Updated: 2022-05-26

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-01-04
• Study Completion Date: 2020-05-04

Brief Summary

This is a single-center, multi-ICU prospective observational trial evaluating current nutritional practice and its influence of the physical function of critically ill patients.

Detailed Description

The investigators propose a prospective observational, single-center, multi-intensive care unit trial to evaluate the influence of current nutritional practice on the physical outcome in critically ill patients. At least 100 consecutive patients requiring surgery, who are admitted to any surgical ICU at the University Hospital RWTH Aachen will be recruited. Nutritional practices, such as dosage, timing and route of administration of the nutrition, as well as complications regarding the nutrition will be recorded and analyzed longitudinally from ICU-admission until hospital discharge. Patient outcomes, such as ICU- and hospital length of stay, duration of mechanical ventilation, organ dysfunction, complications and infections will be evaluated. To assess physical function of the patient, muscle mass, muscle strength, the ability of the patient to self-mobilize and perform every day activities will be measured.

This observational trial aims to assess the current standard of nutritional practice in the ICU, to detect problems and complications and to gather first evidences about the influence of nutrition on the physical function of the patient. This study also aims to compare the outcome of the predefined subgroups of critically ill patients.

Conditions

Neurosurgical Patients; Elderly Patients; Obese Patients; Cardiac Surgery Patients; Abdominal Surgery Patients

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Neurosurgical patients

Non-elective admission to the neurosurgical ICU with one of the following acute intracranial pathologies which also serve as predefined subgroups:

1. Intracranial hemorrhage (subarachnoid, subdural hemorrhage or intracerebral hemorrhage)

2. Acute and severe head trauma with an initial Glasgow Coma Scale ≤10

Functional tests without clinical consequence for the patients therapy

Intervention Type: OTHER

Battery of tests, which measure the patients functional outcomes regarding their muscle mass, their muscle strength, fat mass, physical function, neuropsychological function and quality of life.

Elderly patients

Age ≥ 70 years, predefined subgroups: ≥ 70 years and ≥80 years

Functional tests without clinical consequence for the patients therapy

Intervention Type: OTHER

Battery of tests, which measure the patients functional outcomes regarding their muscle mass, their muscle strength, fat mass, physical function, neuropsychological function and quality of life.

Obese patients

BMI ≥ 35 kg/m2, furthermore predefined subgroups of patients with BMI ≥ 40 kg/m2 and BMI ≥ 45 kg/m2

Functional tests without clinical consequence for the patients therapy

Intervention Type: OTHER

Battery of tests, which measure the patients functional outcomes regarding their muscle mass, their muscle strength, fat mass, physical function, neuropsychological function and quality of life.

Cardiac surgery patients

Admission to the cardiosurgical ICU after one of the following procedures using cardiopulmonary bypass, which also serve as predefined subgroups:

1. Coronary revascularization (coronary artery bypass graft)

2. Heart valve surgery

3. Combined or complex heart surgery

Functional tests without clinical consequence for the patients therapy

Intervention Type: OTHER

Battery of tests, which measure the patients functional outcomes regarding their muscle mass, their muscle strength, fat mass, physical function, neuropsychological function and quality of life.

Abdominal surgical patients

Admission to the abdominal surgery ICU after abdominal surgery

Functional tests without clinical consequence for the patients therapy

Intervention Type: OTHER

Battery of tests, which measure the patients functional outcomes regarding their muscle mass, their muscle strength, fat mass, physical function, neuropsychological function and quality of life.

Interventions

Functional tests without clinical consequence for the patients therapy

Battery of tests, which measure the patients functional outcomes regarding their muscle mass, their muscle strength, fat mass, physical function, neuropsychological function and quality of life.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Informed consent
• Adult patients (≥ 18 years)
• Patients admitted to a surgical ICU requiring surgical Intervention
• Patients requiring sedation and invasive ventilation for ≥ 48 hours
• Patients with an expected ICU-length of stay ≥ 72 hours

Exclusion Criteria

• Pregnant or lactating patients
• Patients already receiving an intense nutrition support (home parenteral or enteral nutrition) in addition to normal nutrition on hospital admission
• Patients with disabling disease (neurological or physical) that prevents them from walking, sitting or standing before ICU admission
• Patients unable to follow orders from the study personnel (language barriers, neurological, psychiatric disorders)
• Death expected within 96 hours after admission due to severity of disease
• Enrolment in an industry sponsored randomized trial within the last 30 days (co-enrolment in academic randomized trials will be considered on a case by case basis)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

RWTH Aachen University

OTHER

Sponsor Role: lead

Responsible Party

Christian Stoppe

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

RWTH Aachen University Hospital

Aachen, North Rhine-Westphalia, Germany

Countries

Germany

Other Identifiers

19-001

Identifier Type: -

Identifier Source: org_study_id