Critical Illness Clinical Trial
Official title:
Single-center, Open-label, Prospective Randomized (Double-Blind) Study on the Use of ReliZORBâ„¢ for the Treatment of Feeding Intolerance in Critically Ill Adults With Multi Organ Failure
Verified date | April 2023 |
Source | Duke University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to determine if the use of ReliZORB improves nutrition tolerance and helps critically ill patients meet their nutrition goals. Subjects in the intensive care unit will be enrolled and randomized 2:1 to receive ReliZORB or placebo cartridges with enteral feedings for 5 days. Blood and stool samples will be collected to test for nutrition and inflammation.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | January 30, 2024 |
Est. primary completion date | July 30, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 89 Years |
Eligibility | Inclusion Criteria: - Admission to Surgical or Medical Intensive Care Unit within 72 hours - Evidence of multi-organ failure - No enteral nutrition started Exclusion Criteria: - Pregnant women and prisoners - Hypotension is attributed to suspected or confirmed cardiogenic shock - Moribund patients (expected to pass within 72h) - Evidence of intestinal obstruction, ischemia, bleeding, perforation, fistulas or tract discontinuity - Sepsis suspected or confirmed due to an abdominal source - C. Difficile or other gastrointestinal infection that may manifest with diarrhea - Constipation as a pre-existing comorbidity - Use of pancreatic hormone stimulant or inhibitor during or immediately prior to hospital admission - Use of parenteral nutrition - Patients receiving cancer-related treatment in the last 6 months |
Country | Name | City | State |
---|---|---|---|
United States | Duke University Hospital | Durham | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Duke University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of episodes of feeding intolerance | To assess the efficacy of ReliZORBâ„¢ in enhancing enteral nutrition tolerance in critically ill adults with multi-organ failure. | 5 days | |
Secondary | Daily maximum rate of enteral nutrition | 5 days | ||
Secondary | Percent of goal nutrition calories achieved daily | 5 days | ||
Secondary | Enteral nutrition formula when goal rate is achieved | 5 days | ||
Secondary | Days from initiation of enteral feedings to achieved goal rate | 5 days | ||
Secondary | Days on achieved goal rate | 5 days | ||
Secondary | Enteral nutrition formula at end of study | 5 days | ||
Secondary | Daily volume of enteral nutrition (in cc) | 5 days | ||
Secondary | Total volume of enteral nutrition administered | 5 days | ||
Secondary | Total calories administered | 5 days | ||
Secondary | Total protein (grams) administered | 5 days |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04551508 -
Delirium Screening 3 Methods Study
|
||
Recruiting |
NCT06037928 -
Plasma Sodium and Sodium Administration in the ICU
|
||
Completed |
NCT03671447 -
Enhanced Recovery After Intensive Care (ERIC)
|
N/A | |
Recruiting |
NCT03941002 -
Continuous Evaluation of Diaphragm Function
|
N/A | |
Recruiting |
NCT04674657 -
Does Extra-Corporeal Membrane Oxygenation Alter Antiinfectives Therapy Pharmacokinetics in Critically Ill Patients
|
||
Completed |
NCT04239209 -
Effect of Intensivist Communication on Surrogate Prognosis Interpretation
|
N/A | |
Completed |
NCT05531305 -
Longitudinal Changes in Muscle Mass After Intensive Care
|
N/A | |
Terminated |
NCT03335124 -
The Effect of Vitamin C, Thiamine and Hydrocortisone on Clinical Course and Outcome in Patients With Severe Sepsis and Septic Shock
|
Phase 4 | |
Completed |
NCT02916004 -
The Use of Nociception Flexion Reflex and Pupillary Dilatation Reflex in ICU Patients.
|
N/A | |
Recruiting |
NCT05883137 -
High-flow Nasal Oxygenation for Apnoeic Oxygenation During Intubation of the Critically Ill
|
||
Completed |
NCT04479254 -
The Impact of IC-Guided Feeding Protocol on Clinical Outcomes in Critically Ill Patients (The IC-Study)
|
N/A | |
Recruiting |
NCT04475666 -
Replacing Protein Via Enteral Nutrition in Critically Ill Patients
|
N/A | |
Not yet recruiting |
NCT04538469 -
Absent Visitors: The Wider Implications of COVID-19 on Non-COVID Cardiothoracic ICU Patients, Relatives and Staff
|
||
Not yet recruiting |
NCT04516395 -
Optimizing Antibiotic Dosing Regimens for the Treatment of Infection Caused by Carbapenem Resistant Enterobacteriaceae
|
N/A | |
Withdrawn |
NCT04043091 -
Coronary Angiography in Critically Ill Patients With Type II Myocardial Infarction
|
N/A | |
Recruiting |
NCT02989051 -
Fluid Restriction Keeps Children Dry
|
Phase 2/Phase 3 | |
Recruiting |
NCT02922998 -
CD64 and Antibiotics in Human Sepsis
|
N/A | |
Completed |
NCT02899208 -
Can an Actigraph be Used to Predict Physical Function in Intensive Care Patients?
|
N/A | |
Completed |
NCT03048487 -
Protein Consumption in Critically Ill Patients
|
||
Recruiting |
NCT02163109 -
Oxygen Consumption in Critical Illness
|