Efficacy and Safety Study of a Low-carbohydrate Tube Feed in Critically Ill Patients Under Insulin Therapy

Aneurysmal Subarachnoid Hemorrhage Clinical Trial

Official title:

Effects of a Diabetes-specific Tube Feed on Glycemic Variability in Critically Ill Patients During Insulin Blood Glucose Management

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02503527
• Other study ID #: DBHP-001-CEN
• Status: Terminated
• Phase: N/A
• Start date: August 2015
• Est. completion date: September 2018

Study information

• Verified date: March 2022
• Source: Fresenius Kabi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine the efficacy and safety of a diabetes-specific tube feed in comparison to an isocaloric, isonitrogenous standard enteral formula in critically ill patients receiving insulin treatment for blood glucose management.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 28
• Est. completion date: September 2018
• Est. primary completion date: August 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Patients with spontaneous aneurysmal subarachnoid hemorrhage (SAH) defined according to Hunt and Hess scale grade HH5
• Requiring mechanical ventilation in the ICU at the time of enrolment
• Enteral nutrition (EN) in the ICU at time of enrolment
• If enrolment on day 3 of ICU stay, EN equal to or larger than 80% of total calories in case of supplementary parenteral nutrition (PN) with anticipated 100% EN as of day 4 to 8 of ICU stay
• If enrolment on day 4 of ICU stay, 100% EN planned for at least 5 days from the time of enrolment
• Patients expected to stay in the ICU for at least 5 days following enrolment
• Age 18 - 75 years
• Glycemic control with intravenous insulin therapy to maintain a target glucose range between 110 mg/dL and 150 mg/dL (6.1 and 8.3 mmol/l)
• Informed consent according to local regulations for decisionally impaired subjects

Exclusion Criteria:

• Patients with septic shock at time of enrolment
• Participation in a clinical trial with any investigational product within 4 weeks before study
• Patients requiring a fibre free diet
• Total or supplementary parenteral nutrition (> 20% of total calories)
• Known or suspected intolerance or allergy to any component of the study product(s), e.g. galactosemia
• Gastrectomy
• Postpyloric nutrition
• Any clinical condition not allowing enteral nutrition (e.g. emesis, severe reflux, severe diarrhea)
• Known severe heart failure (NYHA class 4)
• Liver insufficiency / failure (male: ALAT > 150 U/l; female: ALAT > 120 U/l)
• Acute kidney failure (blood creatinine > 2.5 mg/dl)
• Body Mass Index < 18 or > 35 kg/m²
• Known or suspicion of drug abuse
• Pregnant or breast feeding women
• Patients with diabetes mellitus type I Exclusion After Enrolment (Withdrawal of Subjects)
• Start of PN with more than 20% of total given energy amount/ day
• Insulin infusion stopped unexpectedly for > 12h for non-nutritional reasons
• Discharge from ICU
• Intolerable AEs
• Major protocol violation
• Withdrawal of informed consent
• Discontinuation of study treatment for other reasons

Related Conditions & MeSH terms

• Aneurysmal Subarachnoid Hemorrhage
• Hemorrhage
• Subarachnoid Hemorrhage

Intervention

Other:
• Diben 1.5 kcal HP
Continuous (24h) application according to a standardized enteral feeding protocol via nasogastric tube or percutaneous endoscopic gastrostomy (PEG); pump-assisted application (Charriére (CH) > 8), duration according to patient's tolerance and requirements for a maximum of 5 days. Dosage: 21 - 24 kcal/kg body weight/day (corresponding to 14 to 16 ml/kg body weight/day).
• Fresubin HP Energy Fibre (1.5 kcal)
Continuous (24h) application according to a standardized enteral feeding protocol via nasogastric tube or percutaneous endoscopic gastrostomy (PEG); pump-assisted application (Charriére (CH) > 8), duration according to patient's tolerance and requirements for a maximum of 5 days. Dosage: 21 - 24 kcal/kg body weight/day (corresponding to 14 to 16 ml/kg body weight/day).

Locations

Country	Name	City	State
Austria	Universitätsklinikum Innsbruck	Innsbruck

Sponsors (4)

Lead Sponsor	Collaborator
Fresenius Kabi	dsh statistical services GmbH, International Medical Research - Partner GmbH, OE Clinical Trial Center (KKS) Universität Innsbruck

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood glucose variability (within patient standard deviation of blood glucose values per day)		At Day 3 of intervention or the day prior to switch from intravenous to subcutaneous insulin administration, whichever comes first
Secondary	Glucose variability		Days 2, 4 and 5 of intervention
Secondary	Time to switch from intravenous to subcutaneous insulin administration		Days 1-6, daily
Secondary	Insulin requirements in IU per day		Days 1 - 6, daily
Secondary	Blood glucose levels		Days 1 - 6, daily
Secondary	HbA1c		Days 1, 6, 28
Secondary	Difference between target and given enteral nutrition (Compliance)		Days 2-6, daily
Secondary	Cerebral and subcutaneous microdialysis: glucose		Days 1 - 6, daily
Secondary	Cerebral and subcutaneous microdialysis: lactate/pyruvate ratio		Days 1 - 6, daily
Secondary	Hospital mortality		Day 28
Secondary	ICU mortality		Day 28
Secondary	ICU length of stay		Day 28
Secondary	Days of mechanical ventilation		Day 28
Secondary	Non-gastrointestinal complications (AEs) to enteral nutrition and application		Days 2-6, daily
Secondary	Gastro-intestinal intolerance (AEs, complications)		Days 2-6, daily