Ignite Creation Date:
2024-05-05 @ 6:38 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00512122
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-02-12
First Post:
2007-07-31
Brief Title:
Impact of Early Parenteral Nutrition Completing Enteral Nutrition in Adult Critically Ill Patients
Sponsor:
KU Leuven
Organization:
KU Leuven
Study Overview
Official Title:
Impact of Early Parenteral Nutrition Completing Enteral Nutrition in Adult Critically Ill Patients
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EPaNIC
Brief Summary:
In critically ill patients a strategy aimed at an early delivery of full caloric support with a combination of Enteral Nutrition EN and Parenteral Nutrition PN in conditions preventing hyperglycemia and overfeeding results in shorter ICU and hospital stay and less morbidity as compared to a strategy using only EN
Detailed Description:
Written informed consent will be obtained from the patient or the closest family member or legal guardian The family member or the patient can withdraw from the trial at any time without impact on his treatment or penalty The investigators confirm that this study concerns a condition that directly threatens patient health and that the adult patient not able to give consent suffers from the condition The experiment is essential to confirm the results from earlier research in patients who could consent or from other research methods
On admission patients will be randomly assigned to receive EN combined with early PN or only EN At ICU admission consecutive patients will be randomly assigned to one of these two treatment groups using blinded envelopes stratified according to primary diagnostic category on admission Upon addition of the new study site the numbered en sealed envelopes for randomization stratified according to primary diagnostic category on admission were replaced by an identical digital system allowing central randomization
As initial nutritional support patients randomised to the EN combined with early PN group will receive glucose 20 at 40 mlhr EN will be initiated in the evening of the second ICU hospitalisation day PN will be started the morning of the third ICU hospitalisation day The amount of PN to be given on any particular day will be the difference between calculated caloric needs and the calories delivered by EN the previous 24 hours When EN covers 80 of calculated caloric needs PN will be stopped When the patient is able to eat the parenteral regimen will be reduced and eventually stopped Whenever oral enteral intake is below 50 of calculated caloric needs the PN will be re-started
As initial nutritional support patients randomised to the EN only group will receive glucose 5 at 40 mlhr EN will be initiated on the evening of the second ICU day From the morning of the third ICU hospitalisation day on the amount of glucose 5 to be given will be the same as the volume of PN the patient theoretically would require to receive 100 of presumed caloric needs based on the amount of EN delivered the previous 24 hours When the patient is able to eat the parenteral regimen glucose 5 will be reduced to 50 and eventually stopped Whenever oral enteral intake is below 50 of calculated caloric needs the PN glucose 5 will be re-started If these patients would need to stay for more than seven days on the ICU and enteral feeding of at least 80 of the calculated calories is not possible they will be switched to EN and PN on day eight
Common strategy for attempting early enteral nutrition in both study arms
EN will be initiated on the evening of the second ICU day unless patients are able to eat The increase of enteral feeding volume and the adaptation of the regimen to pathological conditions will be according to protocol Trace elements minerals and vitamins will be administered daily intravenously IV to all patients from the day of admission onwards IV substitution will be stopped in patients receiving at least 1500 ml of EN All patients will be treated following the intensive insulin therapy schedule - targeting a blood glucose level of 80 - 110 mgdl - from admission until discharge or oral feeding
Patients will be weaned from the ventilator according to a standard protocol End-of-care decisions in patients for whom further intensive care is considered to be futile will be taken in consensus by a group of two senior ICU physicians and the referring specialist all blinded to study treatment allocation
In a subgroup of patients pathways of inflammation and metabolism and the endocrinological impact of the intervention will be studied in blood samples and in snap-frozen in vivo biopsies of muscle and adipose tissue Blood and tissue samples from healthy volunteers will serve as references for these exploratory studies In some patients radiological evolution of regional muscle and adipose tissue volumes will be evaluated
On admission patients will be randomly assigned to receive EN combined with early PN or only EN At ICU admission consecutive patients will be randomly assigned to one of these two treatment groups using blinded envelopes stratified according to primary diagnostic category on admission Upon addition of the new study site the numbered en sealed envelopes for randomization stratified according to primary diagnostic category on admission were replaced by an identical digital system allowing central randomization
As initial nutritional support patients randomised to the EN combined with early PN group will receive glucose 20 at 40 mlhr EN will be initiated in the evening of the second ICU hospitalisation day PN will be started the morning of the third ICU hospitalisation day The amount of PN to be given on any particular day will be the difference between calculated caloric needs and the calories delivered by EN the previous 24 hours When EN covers 80 of calculated caloric needs PN will be stopped When the patient is able to eat the parenteral regimen will be reduced and eventually stopped Whenever oral enteral intake is below 50 of calculated caloric needs the PN will be re-started
As initial nutritional support patients randomised to the EN only group will receive glucose 5 at 40 mlhr EN will be initiated on the evening of the second ICU day From the morning of the third ICU hospitalisation day on the amount of glucose 5 to be given will be the same as the volume of PN the patient theoretically would require to receive 100 of presumed caloric needs based on the amount of EN delivered the previous 24 hours When the patient is able to eat the parenteral regimen glucose 5 will be reduced to 50 and eventually stopped Whenever oral enteral intake is below 50 of calculated caloric needs the PN glucose 5 will be re-started If these patients would need to stay for more than seven days on the ICU and enteral feeding of at least 80 of the calculated calories is not possible they will be switched to EN and PN on day eight
Common strategy for attempting early enteral nutrition in both study arms
EN will be initiated on the evening of the second ICU day unless patients are able to eat The increase of enteral feeding volume and the adaptation of the regimen to pathological conditions will be according to protocol Trace elements minerals and vitamins will be administered daily intravenously IV to all patients from the day of admission onwards IV substitution will be stopped in patients receiving at least 1500 ml of EN All patients will be treated following the intensive insulin therapy schedule - targeting a blood glucose level of 80 - 110 mgdl - from admission until discharge or oral feeding
Patients will be weaned from the ventilator according to a standard protocol End-of-care decisions in patients for whom further intensive care is considered to be futile will be taken in consensus by a group of two senior ICU physicians and the referring specialist all blinded to study treatment allocation
In a subgroup of patients pathways of inflammation and metabolism and the endocrinological impact of the intervention will be studied in blood samples and in snap-frozen in vivo biopsies of muscle and adipose tissue Blood and tissue samples from healthy volunteers will serve as references for these exploratory studies In some patients radiological evolution of regional muscle and adipose tissue volumes will be evaluated
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| S 50404 | None | None | None |
| ISRCTN 76223876 | None | None | None |
| EudraCT 2007-000169-40 | None | None | None |