NCT03400046

Brief Summary

Patients who are suffer from CIF often develop muscle wasting because of hypercatabolism.The relationship between different nutrition support formulas and lean body mass is still unclear. The purpose of this study is to investigate the relationship between nutrition support and muscle mass and attempt to find the nutrients which will benefit lean body mass in patients with CIF.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
223

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2013

Longer than P75 for all trials

Status
completed

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

Study Start

First participant enrolled

September 1, 2013

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2017

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 9, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 17, 2018

Completed
Last Updated

January 17, 2018

Status Verified

January 1, 2018

Enrollment Period

4.1 years

First QC Date

January 9, 2018

Last Update Submit

January 9, 2018

Conditions

Nutritional SupportMuscle Loss

Outcome Measures

Primary Outcomes (1)

  • Body composition

    soft lean mass/skeletal muscle mass/fat free mass

    From date of patients enrollment until the date of patients discharge from hospital, assessed up to 2 months.

Interventions

Nutritional Product SupplementationDRUG

Patients with chronic intestinal failure were administered nutritional support including enteral and parenteral nutrition.

Eligibility Criteria

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

Patients treated at a single clinical nutrition center of a tertiary referral hospital in China to investigate the relationship between nutrients and muscle mass in CIF patients. The data used were accumulated at the center between September 2013 and September 2017.

You may qualify if:

  • \- All adult CIF patients (age ≥18 years) receiving nutrition support were included

You may not qualify if:

  • \- Hepatic insufficiency (alanine transaminase/aspartate transaminase ratio 200% above normal range or bilirubin \>3 mg/dL), renal insufficiency (serum creatinine \[Scr\] \>1.5 mg/dL), acute or life-threatening diseases (e.g., shock, collapse, stroke, coma of unknown etiology, or recent cardiac infarction), and pregnant or breast-feeding women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • [1] Bielawska B, Allard JP: Parenteral Nutrition and Intestinal Failure. Nutrients 2017, 9. [2] Pironi L, Arends J, Bozzetti F, Cuerda C, Gillanders L, Jeppesen PB, Joly F, Kelly D, Lal S, Staun M, Szczepanek K, Van Gossum A, Wanten G, Schneider SM: ESPEN guidelines on chronic intestinal failure in adults. Clinical nutrition 2016, 35:247-307. [3] Pironi L: Definitions of intestinal failure and the short bowel syndrome. Best Pract Res Clin Gastroenterol 2016, 30:173-85. [4] Feinberg J, Nielsen EE, Korang SK, Halberg Engell K, Nielsen MS, Zhang K, Didriksen M, Lund L, Lindahl N, Hallum S, Liang N, Xiong W, Yang X, Brunsgaard P, Garioud A, Safi S, Lindschou J, Kondrup J, Gluud C, Jakobsen JC: Nutrition support in hospitalised adults at nutritional risk. The Cochrane database of systematic reviews 2017, 5:Cd011598. [5] Taylor BE, McClave SA, Martindale RG, Warren MM, Johnson DR, Braunschweig C, McCarthy MS, Davanos E, Rice TW, Cresci GA, Gervasio JM, Sacks GS, Roberts PR, Compher C, Society of Critical Care M, the American Society of P, Enteral N: Guidelines for the Provision and Assessment of Nutrition Support Therapy in the Adult Critically Ill Patient: Society of Critical Care Medicine (SCCM) and American Society for Parenteral and Enteral Nutrition (A.S.P.E.N.). Crit Care Med 2016, 44:390-438. [6] McClave SA, DiBaise JK, Mullin GE, Martindale RG: ACG Clinical Guideline: Nutrition Therapy in the Adult Hospitalized Patient. Am J Gastroenterol 2016, 111:315-34.

    BACKGROUND

MeSH Terms

Conditions

Muscular Atrophy

Condition Hierarchy (Ancestors)

Neuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Department General surgery

Study Record Dates

First Submitted

January 9, 2018

First Posted

January 17, 2018

Study Start

September 1, 2013

Primary Completion

September 30, 2017

Study Completion

September 30, 2017

Last Updated

January 17, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share