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The Energy Dose Study

Primary Purpose

Critical Illness

Status

Terminated

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Parenteral Nutrition

Propofol

Clevidipine

Dextrose-containing IV Fluids

Enteral feeding

About this trial

This is an interventional supportive care trial for Critical Illness focused on measuring Surgical Intensive Care Unit (SICU), Calories, Total Parenteral Nutrition (TPN), Tube Feeding, Optimum Energy Dose in SICU, Malnutrition, Hospital-acquired Infection

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

Emory University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Experimental

Arm Label

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

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Number of Participants With Hospital-acquired Infection

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

Secondary Outcome Measures

Number of Participants With Bloodstream Infection

The count of participants acquiring a bloodstream infection during the study period is presented here.

Ventilator Free Days

The mean number of ICU ventilator-free days among participants.

Number of Days in Intensive Care Unit (ICU)

The ICU length of stay (in days) is presented here for each study arm.

Number of Days in Hospital

The hospitalization length of stay (in days) is presented here for each study arm.

Full Information

NCT ID

NCT01369147

First Posted

May 25, 2011

Last Updated

May 18, 2022

Sponsor

Emory University

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

1. Study Identification

Unique Protocol Identification Number

NCT01369147

Brief Title

The Energy Dose Study

Official Title

Comparative Effectiveness of Energy Doses in Critical Illness

Study Type

Interventional

2. Study Status

Record Verification Date

May 2022

Overall Recruitment Status

Terminated

Why Stopped

This study was halted pending additional funding and ultimately was terminated due to difficulties with ongoing recruitment, etc.

Study Start Date

July 2011 (Actual)

Primary Completion Date

December 2, 2014 (Actual)

Study Completion Date

December 2, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Emory University

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed Description

Protein and/or energy deficits are associated with increased rates of hospital infection, skeletal muscle weakness, impaired wound healing, and prolonged convalescence in ICU patients. To prevent or treat malnutrition, enteral nutrition (EN) and/or parenteral nutrition (PN) are routinely given worldwide to a significant proportion of ICU patients. Optimal caloric requirements in critically ill patients are unknown due to a lack of rigorous randomized clinical trials. The comparative efficacy of energy doses in critically ill patients is unknown and clinical recommendations are conflicting and controversial. The primary aim of this study is to perform a controlled, double-blind, prospective, randomized, intent-to-treat Phase II clinical trial to test the efficacy of three specific energy doses on 28-day total hospital-acquired infections (primary endpoint), blood stream infections (BSI), and other important clinical outcomes in medical/surgical ICU patients requiring specialized parenteral ± enteral feeding. The investigators would also determine the impact of cumulative and mean daily 28-day energy deficits on clinical outcome endpoints; the practical utility of estimated resting energy expenditure (REE) determined by Harris-Benedict equation versus measured REE across different energy doses. The investigators would also like to determine the impact of administered energy dose and energy deficits on global metabolomic patterns over time and their association with key clinical outcomes. Participants will be randomized to receive one of three specific energy doses, 0.6, 1.0 and 1.3 times measured REE, given for 28 consecutive days during the ICU and post-ICU course.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Critical Illness

Keywords

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

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

12 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Parenteral nutrition energy dose at 0.6 x measured REE

Arm Type

Experimental

Arm Description

Arm Title

Parenteral nutrition energy dose at 1.0 x measured REE

Arm Type

Active Comparator

Arm Description

Arm Title

Parenteral nutrition energy dose at 1.3 x measured REE

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Parenteral Nutrition

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Propofol

Other Intervention Name(s)

Diprivan

Intervention Description

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).

Intervention Type

Drug

Intervention Name(s)

Clevidipine

Other Intervention Name(s)

Cleviprex

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Dextrose-containing IV Fluids

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Enteral feeding

Intervention Description

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.

Primary Outcome Measure Information:

Title

Number of Participants With Hospital-acquired Infection

Description

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

Time Frame

Up to Day 28

Secondary Outcome Measure Information:

Title

Number of Participants With Bloodstream Infection

Description

The count of participants acquiring a bloodstream infection during the study period is presented here.

Time Frame

Up to Day 28

Title

Ventilator Free Days

Description

The mean number of ICU ventilator-free days among participants.

Time Frame

Up to Day 28

Title

Number of Days in Intensive Care Unit (ICU)

Description

The ICU length of stay (in days) is presented here for each study arm.

Time Frame

Up to 28 Days

Title

Number of Days in Hospital

Description

The hospitalization length of stay (in days) is presented here for each study arm.

Time Frame

Up to Day 28

Other Pre-specified Outcome Measures:

Title

Cumulative 28-day Energy Deficit

Description

The daily energy deficit of kilocalories was calculated by subtracting the calculated mean daily Measured Resting Energy Expenditure (measured using a metabolic cart) from the actual daily energy intake obtained from participant nutrition intake records. The cumulative energy deficit is the sum of daily energy deficits during the time participants were hospitalized, up to 28 days.

Time Frame

Up to Day 28

Title

Mean Daily Energy Deficit

Description

The daily energy deficit of kilocalories was calculated by subtracting the calculated mean daily Measured Resting Energy Expenditure (measured using a metabolic cart) from the actual daily energy intake obtained from participant nutrition intake records. The mean daily energy deficit was calculated during the time participants were hospitalized, up to 28 days.

Time Frame

Up to Day 28

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Thomas R Ziegler, MD

Organizational Affiliation

Emory University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Emory University Hospital

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30322

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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The Energy Dose Study

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