Trial Outcomes & Findings for Enhanced Protein-Energy Provision Via the Enteral Route in Critically Ill Patients (NCT NCT01167595)

Results Overview

Total calories received from enteral nutrition/total prescription up to 12 evaluable ICU days

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

1059 participants

Primary outcome timeframe

first 12 days

Results posted on

2021-04-28

Participant Flow

We conducted a cluster randomized trial of 18 ICUs in North America. Randomizing ICUs rather than individual patients was necessary to minimize the contamination of patients randomized to the usual care group who might have received care that was guided by the PEP uP protocol if it were operational in the same ICU at the same time

Unit of analysis: hospitals

Participant milestones

Participant milestones
Measure	PEP uP Protocol PEP-uP protocol and treatment algorithm implemented for all patients in ICU. PEP uP Protocol: Protocol documents (i.e. pre-printed order, algorithm for advancing feed, and algorithm for calculating rate of administering feed as per 24hour volume) and a slide presentation coupled with educational reminders (posters and bedside notices) and practice helps (tool to remind nurse to measure and report nutritional adequacy) will be made available to all nurses, in bedside manuals and/or on the local intranet.	Standard Feeding Protocol Enteral feeds are guided by a standard feeding protocol specified by pre-printed ICU admission orders. The admitting physician has the option of initiating the enteral feeding protocol or keeping the patient nil per os (NPO).
Overall Study STARTED	522 9	537 9
Overall Study COMPLETED	522 9	537 9
Overall Study NOT COMPLETED	0 0	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

It doesn't the combined baseline and follow up equals the total of the participants to each arm

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	PEP uP Protocol n=9 ICUs PEP-uP protocol and treatment algorithm implemented for all patients in ICU. PEP uP Protocol: Protocol documents (i.e. pre-printed order, algorithm for advancing feed, and algorithm for calculating rate of administering feed as per 24hour volume) and a slide presentation coupled with educational reminders (posters and bedside notices) and practice helps (tool to remind nurse to measure and report nutritional adequacy) will be made available to all nurses, in bedside manuals and/or on the local intranet.	Standard Feeding Protocol n=9 ICUs Enteral feeds are guided by a standard feeding protocol specified by pre-printed ICU admission orders. The admitting physician has the option of initiating the enteral feeding protocol or keeping the patient nil per os (NPO).	Total n=18 ICUs Total of all reporting groups
Age, Continuous Baseline	65.1 years STANDARD_DEVIATION 15.5 • n=270 Participants • It doesn't the combined baseline and follow up equals the total of the participants to each arm	63.4 years STANDARD_DEVIATION 15.1 • n=270 Participants • It doesn't the combined baseline and follow up equals the total of the participants to each arm	64.2 years STANDARD_DEVIATION 15.3 • n=540 Participants • It doesn't the combined baseline and follow up equals the total of the participants to each arm
Sex: Female, Male Baseline · Female	113 Participants n=270 Participants • It doesn't the combined baseline and follow up equals the total of the participants to each arm	100 Participants n=270 Participants • It doesn't the combined baseline and follow up equals the total of the participants to each arm	213 Participants n=540 Participants • It doesn't the combined baseline and follow up equals the total of the participants to each arm
Sex: Female, Male Baseline · Male	157 Participants n=270 Participants • It doesn't the combined baseline and follow up equals the total of the participants to each arm	170 Participants n=270 Participants • It doesn't the combined baseline and follow up equals the total of the participants to each arm	327 Participants n=540 Participants • It doesn't the combined baseline and follow up equals the total of the participants to each arm
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Canada	4 ICUs n=9 ICUs	5 ICUs n=9 ICUs	9 ICUs n=18 ICUs
Region of Enrollment United States	5 ICUs n=9 ICUs	4 ICUs n=9 ICUs	9 ICUs n=18 ICUs

PRIMARY outcome

Timeframe: first 12 days

Population: This was a pre- post cluster RCT where the same 9 ICUs evaluated before and after randomization but the individuals at the ICUs are different. Some outcomes were analyzed at the ICU level while others were analyzed at the participant level. Ergo 522 is the total of 270 participants at baseline + 252 at follow up in the Pep up arm. Similarly in the standard feeding protocol 537= 270 at baseline + 267 at follow up

Total calories received from enteral nutrition/total prescription up to 12 evaluable ICU days

Outcome measures

Outcome measures
Measure	PEP uP Protocol n=9 ICUs PEP-uP protocol and treatment algorithm implemented for all patients in ICU. PEP uP Protocol: Protocol documents (i.e. pre-printed order, algorithm for advancing feed, and algorithm for calculating rate of administering feed as per 24hour volume) and a slide presentation coupled with educational reminders (posters and bedside notices) and practice helps (tool to remind nurse to measure and report nutritional adequacy) will be made available to all nurses, in bedside manuals and/or on the local intranet.	Standard Feeding Protocol n=9 ICUs Enteral feeds are guided by a standard feeding protocol specified by pre-printed ICU admission orders. The admitting physician has the option of initiating the enteral feeding protocol or keeping the patient nil per os (NPO).
Percentage of Prescribed Calories From Energy Baseline time	32 percentage of prescription Standard Deviation 29.4	34.2 percentage of prescription Standard Deviation 30.9
Percentage of Prescribed Calories From Energy Follow-up time	43.6 percentage of prescription Standard Deviation 32.1	33.6 percentage of prescription Standard Deviation 29.5

PRIMARY outcome

Timeframe: first 12 days

Population: This was a pre- post cluster RCT where the same 9 ICUs evaluated before and after randomization but the individuals at the ICUs are different. Some outcomes were analyzed at the ICU level while others were analyzed at the participant level. Ergo 522 is the total of 270 participants at baseline + 252 at follow up in the Pep up arm. Similarly in the standard feeding protocol 537= 270 at baseline + 267 at follow up

Total protein received from enteral nutrition/total prescription up to 12 evaluable ICU days

Outcome measures

Outcome measures
Measure	PEP uP Protocol n=522 Participants PEP-uP protocol and treatment algorithm implemented for all patients in ICU. PEP uP Protocol: Protocol documents (i.e. pre-printed order, algorithm for advancing feed, and algorithm for calculating rate of administering feed as per 24hour volume) and a slide presentation coupled with educational reminders (posters and bedside notices) and practice helps (tool to remind nurse to measure and report nutritional adequacy) will be made available to all nurses, in bedside manuals and/or on the local intranet.	Standard Feeding Protocol n=9 ICUs Enteral feeds are guided by a standard feeding protocol specified by pre-printed ICU admission orders. The admitting physician has the option of initiating the enteral feeding protocol or keeping the patient nil per os (NPO).
Percentage of Prescribed Protein Baseline time	33.6 percentage of prescription Standard Deviation 31.1	34.2 percentage of prescription Standard Deviation 30.9
Percentage of Prescribed Protein Follow-up time	47.4 percentage of prescription Standard Deviation 34.7	33.6 percentage of prescription Standard Deviation 29.5

SECONDARY outcome

Timeframe: 60 days

Population: This was a pre- post cluster RCT where the same 9 ICUs evaluated before and after randomization but the individuals at the ICUs are different. Some outcomes were analyzed at the ICU level while others were analyzed at the participant level. Ergo 522 is the total of 270 participants at baseline + 252 at follow up in the Pep up arm. Similarly in the standard feeding protocol 537= 270 at baseline + 267 at follow up

Time of the initiation of EN from ICU admit

Outcome measures

Outcome measures
Measure	PEP uP Protocol n=9 ICUs PEP-uP protocol and treatment algorithm implemented for all patients in ICU. PEP uP Protocol: Protocol documents (i.e. pre-printed order, algorithm for advancing feed, and algorithm for calculating rate of administering feed as per 24hour volume) and a slide presentation coupled with educational reminders (posters and bedside notices) and practice helps (tool to remind nurse to measure and report nutritional adequacy) will be made available to all nurses, in bedside manuals and/or on the local intranet.	Standard Feeding Protocol n=9 ICUs Enteral feeds are guided by a standard feeding protocol specified by pre-printed ICU admission orders. The admitting physician has the option of initiating the enteral feeding protocol or keeping the patient nil per os (NPO).
Timeliness of Initiation of EN Follow-up time	29.7 hours Standard Deviation 31.4	35.2 hours Standard Deviation 39.2
Timeliness of Initiation of EN Baseline time	40.7 hours Standard Deviation 30.6	33.6 hours Standard Deviation 33.1

SECONDARY outcome

Timeframe: 60 days

Population: This was a pre- post cluster RCT where the same 9 ICUs evaluated before and after randomization but the individuals at the ICUs are different. Some outcomes were analyzed at the ICU level while others were analyzed at the participant level. Ergo 522 is the total of 270 participants at baseline + 252 at follow up in the Pep up arm. Similarly in the standard feeding protocol 537= 270 at baseline + 267 at follow up

Outcome measures

Outcome measures
Measure	PEP uP Protocol n=522 Participants PEP-uP protocol and treatment algorithm implemented for all patients in ICU. PEP uP Protocol: Protocol documents (i.e. pre-printed order, algorithm for advancing feed, and algorithm for calculating rate of administering feed as per 24hour volume) and a slide presentation coupled with educational reminders (posters and bedside notices) and practice helps (tool to remind nurse to measure and report nutritional adequacy) will be made available to all nurses, in bedside manuals and/or on the local intranet.	Standard Feeding Protocol n=537 Participants Enteral feeds are guided by a standard feeding protocol specified by pre-printed ICU admission orders. The admitting physician has the option of initiating the enteral feeding protocol or keeping the patient nil per os (NPO).
Percentage of Participants With Vomiting Baseline time	12 Participants	20 Participants
Percentage of Participants With Vomiting Follow-up time	14 Participants	12 Participants

SECONDARY outcome

Timeframe: 60 days

Population: This was a pre- post cluster RCT where the same 9 ICUs evaluated before and after randomization but the individuals at the ICUs are different. Some outcomes were analyzed at the ICU level while others were analyzed at the participant level. Ergo 522 is the total of 270 participants at baseline + 252 at follow up in the Pep up arm. Similarly in the standard feeding protocol 537= 270 at baseline + 267 at follow up

Outcome measures

Outcome measures
Measure	PEP uP Protocol n=522 Participants PEP-uP protocol and treatment algorithm implemented for all patients in ICU. PEP uP Protocol: Protocol documents (i.e. pre-printed order, algorithm for advancing feed, and algorithm for calculating rate of administering feed as per 24hour volume) and a slide presentation coupled with educational reminders (posters and bedside notices) and practice helps (tool to remind nurse to measure and report nutritional adequacy) will be made available to all nurses, in bedside manuals and/or on the local intranet.	Standard Feeding Protocol n=537 Participants Enteral feeds are guided by a standard feeding protocol specified by pre-printed ICU admission orders. The admitting physician has the option of initiating the enteral feeding protocol or keeping the patient nil per os (NPO).
Percentage of Participants With Pneumonia Baseline time	6 Participants	11 Participants
Percentage of Participants With Pneumonia Follow-up time	7 Participants	16 Participants

Adverse Events

PEP uP Protocol

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard Feeding Protocol

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr.Daren Heyland

CERU Queen's University

Phone: 403-915-5573

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place