Investigating Nutrition and Functional Outcome in Critically Ill Patients

Elderly Patients Clinical Trial

— INFO  

Official title:

Investigating Nutrition and Functional Outcome in Critically Ill Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04180852
• Other study ID #: 19-001
• Status: Completed
• Start date: January 4, 2019
• Est. completion date: May 4, 2020

Study information

• Verified date: May 2022
• Source: RWTH Aachen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: May 4, 2020
• Est. primary completion date: May 4, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Abdominal Surgery Patients
• Cardiac Surgery Patients
• Critical Illness
• Elderly Patients
• Neurosurgical Patients
• Obese Patients

Intervention

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.

Locations

Country	Name	City	State
Germany	RWTH Aachen University Hospital	Aachen	NRW

Sponsors (1)

Lead Sponsor	Collaborator
RWTH Aachen University

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Nutritional status - basic demographics	Chart review	at Study inclusion
Primary	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
Primary	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
Primary	Nutritional Status - Waist and mid-arm circumferences	Waist and mid-arm circumferences	Study inclusion, up to 1 week
Primary	Differences of dosage of nutrition	Cumulative delivery of macronutrients by infusion rates	until discharge from intensive care unit, an average of 30 days
Primary	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
Primary	Differences of dosage of nutrition	Cumulative delivery of macronutrients by nutrition used	until discharge from intensive care unit, an average of 30 days
Primary	Timing of nutrition	Chart Review- start and stop times	until discharge from intensive care unit, an average of 30 days
Primary	Timing of nutrition - reason for discontinuation	Chart review	at discharge from intensive care unit, an average of 30 days
Primary	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
Primary	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
Primary	Incidence Blood work irregularities	Chart review (electrolyte imbalance, blood sugar imbalance, dyslipidemia)	discharge from intensive care unit, an average of 30 days
Primary	Incidence of Refeeding syndrome	Chart review	discharge from intensive care unit, an average of 30 days
Primary	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
Primary	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
Primary	Change in Muscle mass - Mid-arm circumference (MAC)	MAC	Study inclusion, discharge from intensive care unit and hospital discharge, up to 3 months
Primary	Change in Muscle mass - Quadriceps thickness	ultrasound	Study inclusion, discharge from intensive care unit and hospital discharge, up to 3 months
Primary	Change in Muscle mass - Quadriceps cross sectional area	ultrasound	Study inclusion, discharge from intensive care unit and hospital discharge, up to 3 months
Primary	Change in Muscle strength - Handgrip strength	Dynamometry	discharge from intensive care unit and hospital discharge, up to 3 months
Primary	Change in Muscle strength - Quadriceps strength	Dynamometry	discharge from intensive care unit and hospital discharge, up to 3 months
Primary	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
Primary	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
Primary	Change in Physical function - 6-Minute Walk Test	6-minute walking distance	discharge from intensive care unit and hospital discharge, up to 3 months
Primary	Change in Physical function - Manual Muscle Testing (MMT)	MMT	discharge from intensive care unit and hospital discharge, up to 3 months
Primary	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
Primary	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
Primary	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
Primary	Change in Fat mass	Thigh and abdominal fat (ultrasound)	Study inclusion, discharge from intensive care unit and hospital discharge, up to 3 months
Primary	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
Primary	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
Primary	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
Primary	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	Mortality Rate	Mortality	up to 30 days after study inclusion
Secondary	Length of stay - intensive care unit length of stay	ICU length of stay	discharge from intensive care unit, an average of 30 days
Secondary	Length of stay - Hospital length of stay	Hospital length of stay	Hospital discharge, an average of 60 days
Secondary	Readmission - ICU readmission rate	ICU readmission rate	Hospital discharge, day 30 after study inclusion, up to 3 months
Secondary	Readmission - Hospital readmission rate	Hospital readmission rate	up to 30 days after study inclusion, up to 3 months
Secondary	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
Secondary	Acute organ dysfunction - hemodynamic parameters	blood pressure in mmHg	up to discharge from intensive care unit, an average of 30 days
Secondary	Acute organ dysfunction - hemodynamic parameters	vasopressors, cumulative dosage in ml/d	up to discharge from intensive care unit, an average of 30 days
Secondary	Acute organ dysfunction - hemodynamic parameters	heart rate bpm	up to discharge from intensive care unit, an average of 30 days
Secondary	Acute organ dysfunction - incidence of ventilation	mode of ventilation	up to discharge from intensive care unit, an average of 30 days
Secondary	Acute organ dysfunction - duration of ventilation	hours of ventilation	up to discharge from intensive care unit, an average of 30 days
Secondary	Acute organ dysfunction - sedation	duration of sedation in hours	up to discharge from intensive care unit, an average of 30 days
Secondary	Acute organ dysfunction - sedation	dosage of sedation, cumulative dosage in ml/d	up to discharge from intensive care unit, an average of 30 days
Secondary	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
Secondary	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
Secondary	Persistent Organ Dysfunction - Incidence of mechanical ventilation	need for ventilation	Hospital discharge, day 30 after study inclusion, up to 3 months
Secondary	Persistent Organ Dysfunction - Incidence of hemodynamic parameters	vasopressors	Hospital discharge, day 30 after study inclusion, up to 3 months
Secondary	Persistent Organ Dysfunction - Incidence of renal replacement therapy	renal replacement therapy	Hospital discharge, day 30 after study inclusion, up to 3 months
Secondary	Complications - Rate of surgical reevaluation	surgical reevaluation	Hospital discharge, day 30 after study inclusion, up to 3 months
Secondary	Complications - Rate of hemorrhage	hemorrhage	Hospital discharge, day 30 after study inclusion, up to 3 months
Secondary	Complications - Rate of thromboembolic events	thromboembolic events	Hospital discharge, day 30 after study inclusion, up to 3 months
Secondary	Complications - Rate of cardiovascular events	cardiovascular events	Hospital discharge, day 30 after study inclusion, up to 3 months
Secondary	Complications - Rate of infection	infection	Hospital discharge, day 30 after study inclusion, up to 3 months
Secondary	Complications - Rate of sepsis	sepsis	Hospital discharge, day 30 after study inclusion, up to 3 months