NCT03277300

Brief Summary

Supplementation of insufficient enteral nutrition with parenteral nutrition may optimize nutritional support and avert negative energy balance in critically ill patients, thereby improving outcome.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2018

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 28, 2017

Completed
14 days until next milestone

First Posted

Study publicly available on registry

September 11, 2017

Completed
4 months until next milestone

Study Start

First participant enrolled

January 1, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2019

Completed
Last Updated

September 11, 2017

Status Verified

September 1, 2017

Enrollment Period

1 year

First QC Date

August 28, 2017

Last Update Submit

September 7, 2017

Conditions

Critical Illness

Outcome Measures

Primary Outcomes (1)

  • ts Overall mortality

    Determined by hospital records.

    one year

Interventions

dietary supplementDIETARY_SUPPLEMENT

good dietary supplement for critically ill patients

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Data will be collected and analyzed using SPSS version 20. Normally distributed data will be expressed in form of mean and SD while not normally distributed data will be expressed in form of median and range. Nominal data will be expressed in form of frequency (percentage). P value will be significant if \< 0.05.

You may qualify if:

  • All patients admitted to CCU (critical care unit)who are in need for either enteral or parenteral during duration of the study will be included

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • DerSimonian R, Laird N. Meta-analysis in clinical trials. Control Clin Trials. 1986 Sep;7(3):177-88. doi: 10.1016/0197-2456(86)90046-2.

    PMID: 3802833BACKGROUND

  • Cahill NE, Dhaliwal R, Day AG, Jiang X, Heyland DK. Nutrition therapy in the critical care setting: what is "best achievable" practice? An international multicenter observational study. Crit Care Med. 2010 Feb;38(2):395-401. doi: 10.1097/CCM.0b013e3181c0263d.

    PMID: 19851094BACKGROUND

MeSH Terms

Conditions

Critical Illness

Interventions

Dietary Supplements

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

FoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • NoorEldeen AbdElazeem, professor

    Assiut University

    STUDY CHAIR

Central Study Contacts

Ahmed Mohamed

CONTACT

+2001140148703ahmedeltemway1989@outlook.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
doctor

Study Record Dates

First Submitted

August 28, 2017

First Posted

September 11, 2017

Study Start

January 1, 2018

Primary Completion

January 1, 2019

Study Completion

January 30, 2019

Last Updated

September 11, 2017

Record last verified: 2017-09