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Effects of Delayed Enteral Nutrition on Inflammatory Responses and Immune Function Competence in Critically Ill Patients With Prolonged Fasting

Effects of Delayed Enteral Nutrition on Inflammatory Responses and Immune Function Competence in Critically Ill Patients With Prolonged Fasting

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01834430
Enrollment
45
Registered
2013-04-17
Start date
2010-02-28
Completion date
Unknown
Last updated
2013-04-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Duodenal Fistula, Inflammatory Intestinal Obstruction, Severe Acute Pancreatitis Patients

Brief summary

Different studies suggest that early enteral nutrition (EEN) has benefits in reducing infectious complications, there is no data that addresses whether delayed enteral nutrition (EN) is detrimental and if it may have effects on inflammatory responses and immune function.

Interventions

DIETARY_SUPPLEMENTenteral nutrition

Sponsors

Nanjing PLA General Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

Inclusion criteria

* having a fasting time of more than 14 days * American Society of Anesthesiologists (ASA) physical status ranging between 1 and 3, and their condition allows enteral nutrition therapy.

Exclusion criteria

* chronic renal failure (peritoneal or hemodialysis or creatinine \> 2.5 mg/dl) * history of chronic obstructive pulmonary disease * hepatic dysfunction or cirrhosis or a bilirubin value \> 3 mg/dl * metabolic diseases,severe anemia * blood coagulation dysfunction * pregnancy lactation * history of psychiatric illness * patients underwent immunosuppressive therapy

Design outcomes

Primary

MeasureTime frame
all cause mortality28 days

Secondary

MeasureTime frame
organ failure7 days

Other

MeasureTime frameDescription
inflammatory markers7 dayswhite blood cell count, C reactive protein(CRP), pro-inflammatory cytokines (TNF-a,IL-1,IL-6), and anti-inflammatory cytokines (IL-4, IL-10)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026