Investigating Nutrition and Functional Outcome in Critically Ill Patients (INFO)

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.

Study Overview

• Status: Completed
• Conditions: Cardiac Surgery Patients; Elderly Patients; Neurosurgical Patients; Obese Patients; Abdominal Surgery Patients
• Intervention / Treatment: Other: Functional tests without clinical consequence for the patients therapy

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.

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• Germany
  • NRW
    • Aachen, NRW, Germany, 52074
      • RWTH Aachen University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

This is a clinical trial, which will include critically ill patients after informed consent. Patients who admitted to a surgical ICU following surgery or requiring surgery can be screened and included by our team. The general eligibility criteria are listed above. We will recruit patients, who can be classified as one of the following groups: a) neurosurgical Patients, b) elderly patients, c) obese patients, d) cardiac surgery patients and e) abdominal surgery patients

Description

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)

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

5

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Neurosurgical patients; Non-elective admission to the neurosurgical ICU with one of the following acute intracranial pathologies which also serve as predefined subgroups: Intracranial hemorrhage (subarachnoid, subdural hemorrhage or intracerebral hemorrhage); Acute and severe head trauma with an initial Glasgow Coma Scale ≤10	Other: 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.
Elderly patients; Age ≥ 70 years, predefined subgroups: ≥ 70 years and ≥80 years	Other: 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.
Obese patients; BMI ≥ 35 kg/m2, furthermore predefined subgroups of patients with BMI ≥ 40 kg/m2 and BMI ≥ 45 kg/m2	Other: 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.
Cardiac surgery patients; Admission to the cardiosurgical ICU after one of the following procedures using cardiopulmonary bypass, which also serve as predefined subgroups: Coronary revascularization (coronary artery bypass graft); Heart valve surgery; Combined or complex heart surgery	Other: 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.
Abdominal surgical patients; Admission to the abdominal surgery ICU after abdominal surgery	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nutritional status - basic demographics	Chart review	at Study inclusion
Nutritional Status - nutritional screening	Nutritional Risk Screening 2002 (Score: 0-7; if ≥3 patient at nutritional risk)	intensive care unit (ICU) admission, up to 1 week
Nutritional Status - nutritional risk in the critically ill (NUTRIC)	NUTRIC score (Score 0-10; if interleucin-6 (IL6) available 0-5=low malnutrition risk; if IL6 not available 0-4= at low malnutrition risk	ICU admission, up to 1 week
Nutritional Status - Waist and mid-arm circumferences	Waist and mid-arm circumferences	Study inclusion, up to 1 week
Differences of dosage of nutrition	Cumulative delivery of macronutrients by infusion rates	until discharge from intensive care unit, an average of 30 days
Differences of dosage of nutrition	Cumulative delivery of macronutrients by cumulative count of macronutrients	until discharge from intensive care unit, an average of 30 days
Differences of dosage of nutrition	Cumulative delivery of macronutrients by nutrition used	until discharge from intensive care unit, an average of 30 days
Timing of nutrition	Chart Review- start and stop times	until discharge from intensive care unit, an average of 30 days
Timing of nutrition - reason for discontinuation	Chart review	at discharge from intensive care unit, an average of 30 days
Differences in route of administration of nutrition	Rates of oral, enteral and parenteral nutrition, feeding tubes and catheters used for nutrition	discharge from intensive care unit, an average of 30 days
Incidence of Gastrointestinal symptoms	Chart review (vomiting, nausea, high gastric residual volumes, diarrhea, obstipation, aspiration, ileus, bowel ischemia)	discharge from intensive care unit, an average of 30 days
Incidence Blood work irregularities	Chart review (electrolyte imbalance, blood sugar imbalance, dyslipidemia)	discharge from intensive care unit, an average of 30 days
Incidence of Refeeding syndrome	Chart review	discharge from intensive care unit, an average of 30 days
Incidence of complications related to the route of administration	Chart review (central venous catheter infection, misplaced and dislocated enteral feeding tubes)	discharge from intensive care unit, an average of 30 days
Nutrition adequacy	Rates of energy and protein received in comparison to nutritional targets Chart review	discharge from intensive care unit, an average of 30 days
Change in Muscle mass - Mid-arm circumference (MAC)	MAC	Study inclusion, discharge from intensive care unit and hospital discharge, up to 3 months
Change in Muscle mass - Quadriceps thickness	ultrasound	Study inclusion, discharge from intensive care unit and hospital discharge, up to 3 months
Change in Muscle mass - Quadriceps cross sectional area	ultrasound	Study inclusion, discharge from intensive care unit and hospital discharge, up to 3 months
Change in Muscle strength - Handgrip strength	Dynamometry	discharge from intensive care unit and hospital discharge, up to 3 months
Change in Muscle strength - Quadriceps strength	Dynamometry	discharge from intensive care unit and hospital discharge, up to 3 months
Change in Physical function - Functional Status Score for the ICU	Functional Status Score for Intensive Care Unit (FSS-ICU) (Score 0-35; the higher the score, the better physical functioning)	discharge from intensive care unit and hospital discharge, up to 3 months
Change in Physical function - Short Physical Performance Battery	Short Physical Performance Battery (SPPB) (Score: 0-12; 0=worst performance and 12=best performance)	discharge from intensive care unit and hospital discharge, up to 3 months
Change in Physical function - 6-Minute Walk Test	6-minute walking distance	discharge from intensive care unit and hospital discharge, up to 3 months
Change in Physical function - Manual Muscle Testing (MMT)	MMT	discharge from intensive care unit and hospital discharge, up to 3 months
Change in Physical function - Katz Activities of Daily Living (ADL)	ADL (Score: 0-100; the higher the more independent)	Hospital discharge, day 30 after study inclusion, up to 3 months
Change in Physical function - Lawton Instrumental Activities of Daily Living (IADL)	IADL (score 0-8; the higher the more independent)	Hospital discharge, day 30 after study inclusion, up to 3 months
Change in Physical function - Clinical Frailty Score (CFS)	CFS (score 1-9; 1= Very fit and 9=terminally ill)	Study inclusion, Hospital discharge, day 30 after study inclusion, up to 3 months
Change in Fat mass	Thigh and abdominal fat (ultrasound)	Study inclusion, discharge from intensive care unit and hospital discharge, up to 3 months
Change in Neuro-psychological function - Mini Mental State Examination (MMSE)	MMSE (Score 0-30; 30= no dementia and <9= severe dementia)	discharge from intensive care unit, Hospital discharge, day 30 after study inclusion, up to 3 months
Change in Neuro-psychological function - Becks Depression Inventory (BDI)	BDI (Score 0-63; 0= no depression and 63= severe depression)	discharge from intensive care unit, Hospital discharge, day 30 after study inclusion, up to 3 months
Quality of life - Short Form 36 (SF-36)	SF-36 (Score: 0-100; 100=no limitation in daily life and 0=completely limited)	day 30 after study inclusion
Quality of life - Living location	Rates of patients being discharged to nursing home, rehabilitation, home care etc. Discharge location used as surrogate for physical fitness after hospital discharge.	day 30 after study inclusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality Rate	Mortality	up to 30 days after study inclusion
Length of stay - intensive care unit length of stay	ICU length of stay	discharge from intensive care unit, an average of 30 days
Length of stay - Hospital length of stay	Hospital length of stay	Hospital discharge, an average of 60 days
Readmission - ICU readmission rate	ICU readmission rate	Hospital discharge, day 30 after study inclusion, up to 3 months
Readmission - Hospital readmission rate	Hospital readmission rate	up to 30 days after study inclusion, up to 3 months
Change in acute organ dysfunction - sepsis-related organ failure assessment (SOFA score)	daily records (score 0-24; 0=normal function and 24= massively impaired function)	up to discharge from intensive care unit, an average of 30 days
Acute organ dysfunction - hemodynamic parameters	blood pressure in mmHg	up to discharge from intensive care unit, an average of 30 days
Acute organ dysfunction - hemodynamic parameters	vasopressors, cumulative dosage in ml/d	up to discharge from intensive care unit, an average of 30 days
Acute organ dysfunction - hemodynamic parameters	heart rate bpm	up to discharge from intensive care unit, an average of 30 days
Acute organ dysfunction - incidence of ventilation	mode of ventilation	up to discharge from intensive care unit, an average of 30 days
Acute organ dysfunction - duration of ventilation	hours of ventilation	up to discharge from intensive care unit, an average of 30 days
Acute organ dysfunction - sedation	duration of sedation in hours	up to discharge from intensive care unit, an average of 30 days
Acute organ dysfunction - sedation	dosage of sedation, cumulative dosage in ml/d	up to discharge from intensive care unit, an average of 30 days
Acute organ dysfunction - Richmond Agitation Scale	Richmond Agitation Scale (score: +4 - -5; +4=aggressive behavior, 0=calm,-5=not reacting to verbal or physical approaches)	up to discharge from intensive care unit, an average of 30 days
Acute organ dysfunction - Confusion Assessment Method for the ICU (CAM-ICU)	CAM-ICU (score: 0-10; more than 2 errors= delirium)	up to discharge from intensive care unit, an average of 30 days
Persistent Organ Dysfunction - Incidence of mechanical ventilation	need for ventilation	Hospital discharge, day 30 after study inclusion, up to 3 months
Persistent Organ Dysfunction - Incidence of hemodynamic parameters	vasopressors	Hospital discharge, day 30 after study inclusion, up to 3 months
Persistent Organ Dysfunction - Incidence of renal replacement therapy	renal replacement therapy	Hospital discharge, day 30 after study inclusion, up to 3 months
Complications - Rate of surgical reevaluation	surgical reevaluation	Hospital discharge, day 30 after study inclusion, up to 3 months
Complications - Rate of hemorrhage	hemorrhage	Hospital discharge, day 30 after study inclusion, up to 3 months
Complications - Rate of thromboembolic events	thromboembolic events	Hospital discharge, day 30 after study inclusion, up to 3 months
Complications - Rate of cardiovascular events	cardiovascular events	Hospital discharge, day 30 after study inclusion, up to 3 months
Complications - Rate of infection	infection	Hospital discharge, day 30 after study inclusion, up to 3 months
Complications - Rate of sepsis	sepsis	Hospital discharge, day 30 after study inclusion, up to 3 months

Collaborators and Investigators

• Sponsor: RWTH Aachen University

Study record dates

Study Major Dates

• Study Start (Actual): January 4, 2019
• Primary Completion (Actual): May 4, 2020
• Study Completion (Actual): May 4, 2020

Study Registration Dates

• First Submitted: November 7, 2019
• First Submitted That Met QC Criteria: November 25, 2019
• First Posted (Actual): November 29, 2019

Study Record Updates

• Last Update Posted (Actual): May 26, 2022
• Last Update Submitted That Met QC Criteria: May 25, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: 19-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No