The Energy Dose Study

NCT01369147 | Terminated Phase 2 Results DMC FDA Drug

• 2 other identifiers: IRB000494951R21DK089369
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators have designed this single-center Randomized Clinical Trial (RCT) to prospectively compare, for the first time, the clinical efficacy of different energy doses in intensive care unit (ICU) patients requiring parenteral nutrition (PN) due to intestinal failure/dysfunction. This study intends to enroll a total of 60 patients (20 per energy dose group) to generate critical preliminary data needed to inform subsequent appropriately powered Phase III multicenter trials.

Conditions

Critical Illness

Keywords

Surgical Intensive Care Unit (SICU); Calories; Total Parenteral Nutrition (TPN); Tube Feeding; Optimum Energy Dose in SICU; Malnutrition; Hospital-acquired Infection

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Hospital-acquired Infection

  The number of participants with a hospital-acquired infection during the study period is presented here.

  Up to Day 28

Secondary Outcomes (4)

• Number of Participants With Bloodstream Infection

  Up to Day 28

• Ventilator Free Days

  Up to Day 28

• Number of Days in Intensive Care Unit (ICU)

  Up to 28 Days

• Number of Days in Hospital

  Up to Day 28

Other Outcomes (2)

• Cumulative 28-day Energy Deficit

  Up to Day 28

• Mean Daily Energy Deficit

  Up to Day 28

Study Arms (3)

Parenteral nutrition energy dose at 0.6 x measured REE

EXPERIMENTAL

Participants in this study arm will be provided a total daily calorie (kcal) intake at 0.6 x REE for up to 28 days. The dose of parenteral nutrition (PN) will be adjusted taking into account any calories from propofol, clevidipine, dextrose-containing IV fluids surpassing 500 mL/day, and any enteral feedings, to obtain the energy dose that the participant was randomized to receive.

Drug: Parenteral Nutrition; Drug: Propofol; Drug: Clevidipine; Drug: Dextrose-containing IV Fluids; Drug: Enteral feeding

Parenteral nutrition energy dose at 1.0 x measured REE

ACTIVE COMPARATOR

Participants in this study arm will be provided a total daily calorie (kcal) intake at 1.0 x REE for up to 28 days. The dose of PN will be adjusted taking into account any calories from propofol, clevidipine, dextrose-containing IV fluids surpassing 500 mL/day, and any enteral feedings, to obtain the energy dose that the participant was randomized to receive.

Drug: Parenteral Nutrition; Drug: Propofol; Drug: Clevidipine; Drug: Dextrose-containing IV Fluids; Drug: Enteral feeding

Parenteral nutrition energy dose at 1.3 x measured REE

EXPERIMENTAL

Participants in this study arm will be provided a total daily calorie (kcal) intake at 1.3 x REE for up to 28 days. The dose of PN will be adjusted taking into account any calories from propofol, clevidipine, dextrose-containing IV fluids surpassing 500 mL/day, and any enteral feedings, to obtain the energy dose that the participant was randomized to receive.

Drug: Parenteral Nutrition; Drug: Propofol; Drug: Clevidipine; Drug: Dextrose-containing IV Fluids; Drug: Enteral feeding

Interventions

Parenteral Nutrition DRUG

The PN dose will be written for each 24-hr period taking into account any kilocalories (kcal) provided as part of standard of care from propofol, clevidipine, dextrose-containing IV fluid exceeding 500 mL/day, and enteral feedings.

Parenteral nutrition energy dose at 0.6 x measured REE; Parenteral nutrition energy dose at 1.0 x measured REE; Parenteral nutrition energy dose at 1.3 x measured REE

Propofol DRUG

The PN dose will be written for each 24-hr period taking into account calories provided as lipid emulsion in the sedative propofol (1.1 kcal/mL).

Also known as: Diprivan

Parenteral nutrition energy dose at 0.6 x measured REE; Parenteral nutrition energy dose at 1.0 x measured REE; Parenteral nutrition energy dose at 1.3 x measured REE

Clevidipine DRUG

The PN dose will be written for each 24-hr period taking into account calories provided as lipid emulsion in clevidipine (2 kcal/mL).

Also known as: Cleviprex

Parenteral nutrition energy dose at 0.6 x measured REE; Parenteral nutrition energy dose at 1.0 x measured REE; Parenteral nutrition energy dose at 1.3 x measured REE

Dextrose-containing IV Fluids DRUG

The PN dose will be written for each 24-hr period taking into account calories provided from dextrose-containing IV fluid orders exceeding 500 mL/day.

Parenteral nutrition energy dose at 0.6 x measured REE; Parenteral nutrition energy dose at 1.0 x measured REE; Parenteral nutrition energy dose at 1.3 x measured REE

Enteral feeding DRUG

Enteral nutrition is caloric intake through the gastrointestinal (GI) tract via food consumed through the mouth or a feeding tube delivering nutrition directly to the stomach or small intestines. The PN dose will be written for each 24-hr period taking into account calories provided from any enteral feedings.

Parenteral nutrition energy dose at 0.6 x measured REE; Parenteral nutrition energy dose at 1.0 x measured REE; Parenteral nutrition energy dose at 1.3 x measured REE

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A signed informed consent is in place on the patient's chart
• The patient is at least 18 but not more than 90 years of age at time of ICU admission
• The patient has a body mass index (BMI) less than 40 kg/m\^2
• The patient has been admitted to either a medical or surgical (non-neurological) ICU and is expected to survive and remain in the ICU for at least 72 hours after entry
• There is central venous access for administration of the study PN
• The patient's primary physician(s) will allow the investigative team to manage the study PN and enteral feedings during the current hospitalization
• The patient is expected to require total or partial central venous PN for 7 or more subsequent days after entry on a clinical basis

You may not qualify if:

• The patient is pregnant
• The patient has unresuscitated clinical sepsis, defined as unstable blood pressure despite vasopressor support and mean arterial pressure (MAP) \< 60 mm Hg on at least 3 consecutive readings within a 3-hour period during the 24 hours prior to study entry
• The patient was admitted to the ICU following trauma or burns
• The patient has significant renal dysfunction (defined as serum creatinine \> 2.5 mg/dL or deemed to have significant acute kidney injury by the primary physicians) and is not receiving continuous renal replacement therapy (CRRT) or intermittent hemodialysis
• The patient has previously undergone an organ transplantation
• The patient has a current malignancy or is currently receiving an active regimen of chemotherapy and/or radiotherapy to treat a previously diagnosed malignancy
• The patient has a history of HIV/AIDS
• The patient has received any investigational drug within 60 days prior to study entry
• The patient is unable or unwilling to participate in study procedures such as longitudinal blood draws and administration of study nutrient formulations

Sponsors & Collaborators

• Emory University: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Critical Illness; Hyperphagia; Malnutrition; Cross Infection

Interventions

Parenteral Nutrition; Propofol; clevidipine; Enteral Nutrition

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive; Signs and Symptoms; Nutrition Disorders; Nutritional and Metabolic Diseases; Infections; Iatrogenic Disease

Intervention Hierarchy (Ancestors)

Feeding Methods; Therapeutics; Nutritional Support; Nutrition Therapy; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Results Point of Contact

• Title: Thomas Ziegler, MD
• Organization: Emory University

tzieg01@emory.edu

404-727-7351

Study Officials

• Thomas R Ziegler, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: May 25, 2011
• First Posted: June 8, 2011
• Study Start: July 1, 2011
• Primary Completion: December 2, 2014
• Study Completion: December 2, 2014
• Last Updated: June 10, 2022
• Results First Posted: June 10, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)