Study Stopped
discontinued prematurely by sponsor for strategic reasons
Pectin Supplemented Enteral Feedings in Critically Ill Patients
The Effect of Pectin Supplement on Enteral Nutrition-related Complications in Critically Ill Patients
1 other identifier
interventional
N/A
1 country
7
Brief Summary
The current study will enroll critically ill patients who are going to require enteral nutrition support and randomize them to standard formula enteral nutrition or pectin-supplemented enteral nutrition in 7 days. The occurrence of enteral nutrition-related complications will be recorded and compared between groups. The study is trying to assess whether the use of pectin will improve the enteral nutrition-related complications in critically ill patients.
Trial Health
Trial Health Score
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Started Jul 2020
7 active sites
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 17, 2020
CompletedFirst Posted
Study publicly available on registry
June 18, 2020
CompletedStudy Start
First participant enrolled
July 30, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2021
CompletedJuly 15, 2021
July 1, 2021
4 months
June 17, 2020
July 14, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Complication of enteral feeding
Record daily diarrhea ,complications, aspiration pneumonia,poor gastric emptying
7 days
Secondary Outcomes (2)
feeding time of enteral nutrition
7 days
total energy intake
7 days
Study Arms (2)
Pectin
EXPERIMENTALsequential supplementation with combination of 90ml pectin and 500ml enteral nutrition formula for 7 days
Control
PLACEBO COMPARATORstandard formula enteral nutrition feeding without pectin for 7 days
Interventions
sequential supplementation with combination of 90ml pectin and 500ml enteral nutrition formula for 7 days
standard formula enteral nutrition feeding without pectin for 7 days
Eligibility Criteria
You may qualify if:
- Patients aged 18-80 years old, with informed consent to participate;
- Critically ill patients who require enteral nutrition support
You may not qualify if:
- Patients with lung infection at admission
- Condition which contraindicates enteral feeding (i.e. intestinal obstruction)
- Lack of enteral access
- Any condition that would contraindicate use of the enteral nutrition
- Require enteral nutrition support for less than 1week or more than 4 weeks from enrollment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
The Second Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009, China
Huzhou central hospital
Huzhou, Zhejiang, 313003, China
The first hospital of Jiaxing
Jiaxing, Zhejiang, 314001, China
Jinhua municipal central hospital
Jinhua, Zhejiang, 321000, China
Quzhou Kecheng People's Hospital
Quzhou, Zhejiang, 324000, China
Taizhou Hospital of Zhejiang Province
Taizhou, Zhejiang, 317099, China
The first affiliated hospital of Wenzhou medical university
Wenzhou, Zhejiang, 325000, China
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Pianhong Zhang, MS
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 17, 2020
First Posted
June 18, 2020
Study Start
July 30, 2020
Primary Completion
December 1, 2020
Study Completion
December 1, 2021
Last Updated
July 15, 2021
Record last verified: 2021-07