An interventional study of Caloric delivery will target results of IC measurement. in Sepsis, Critical Illness and Respiratory Failure, sponsored by Baylor Research Institute. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-10-22.
Sponsored by Baylor Research Institute · Not applicable, Interventional, and Treatment
Among 517 studies in Sepsis with a site in United States — 75 open to participants now, 99 under way, 3 of them phase 3. Sepsis · United States.
Among the 517 studies in Sepsis with a site in United States, this one is the 233rd largest by enrollment of the 310 interventional ones that give a count, is one of 25 that started in 2018, is one of 140 with no phase, and was the 289th registered.
2,417 studies on the registry are indexed under Sepsis; 542 are open to participants now.
Browse Sepsis studies →75 of the 517 studies in Sepsis with a site in United States are open now. Recruiting first, the newest first:
Deepull Diagnostics S.L. · Sites in United States, France, Germany and 2 more countries
Intermountain Health Care, Inc. · Sites in United States
Ages 18+
Bassett Healthcare · Sites in United States
Ages 18+
Duke University · Sites in United States
Ages 0 days–7 days
Vanderbilt University Medical Center · Sites in United States
Ages 1 days–12 mo
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 318 Sepsis studies recruiting now, 213 (67%) set no upper age limit and 53 (17%) stop at 75 or younger; 68 take children under 18; 42 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
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517 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 50 · Phase 2 80 · Phase 3 47 · Phase 4 25
First in 1988; this study’s year is marked. 25 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 25 is below the median of 102 across 1,166 interventional studies indexed under Sepsis.
Median enrollment 84 across the 310 interventional studies, 183 across the 204 observational. Of the 361 that completed or were terminated, 117 (32%) have results posted.
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135 of 517 have an industry lead sponsor. The 10 most frequent:
Baylor Research Institute is the lead sponsor of 223 studies on the registry; 48 are open to participants now.
Of its 23 completed or terminated interventional studies of FDA-regulated products, 9 (39%) have results posted.
Baylor Research Institute has 2 studies filed under Sepsis — fewer than ten, so there is no comparison to draw.
36 of the studies in Sepsis with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06817408Mayo ClinicDynamics of Organ Damage and Immune Exhaustion During Sepsis | 2026-12 |
| NCT04796285Brigham and Women's HospitalA Validation Study of the Lab Clasp Device: A Point of Care Sepsis Risk Monitor | 2026-12 |
| NCT01315782The University of Texas Health Science Center, HoustonAlveolar Dead Space as Predictor of Organ Failure in Severe Sepsis | 2026-12 |
| NCT06692400Loma Linda UniversityThe Effects of Endotracheal Suctioning on Pain and Serum Markers | 2026-12 |
| NCT03133208University of FloridaSepsis Associated Encephalopathy (SAE) Biomarkers | 2026-12-15 |
Add all 36 to your calendar (.ics) → With an account.
Among the 517 studies in Sepsis with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
Patients admitted to the ICU with diagnosis of sepsis and requiring mechanical ventilation for at least 24-hours and receiving enteral or parenteral nutrition will be prospectively randomized to one of two arms. Patients allocated to the estimated energy expenditure group will receive nutrition with caloric intake calculated based on the Penn State equation. Patients randomized to the measured group will receive nutrition with caloric intake calculated based on IC measurement present in the GE ventilator. Patients in the estimated group will have IC performed, but these data will not be used for prescription of nutrition. An equal number of beds within the ICU will be allocated to the measured group and the estimated group. The primary objective is to assess whether the utilization of indirect calorimetry for caloric goal calculation results in improvement in muscular structure, and consequent reduction of mechanical ventilation duration in patients with sepsis in comparison to utilizing the Penn State estimation equation for caloric goal calculation. The secondary objective is to assess whether the utilization of indirect calorimetry for caloric goal calculation results in improved adequacy of nutritional delivery in comparison to the adequacy of nutritional delivered when utilizing the Penn State estimation equation. Adult patients (> 18 years of age) admitted to the hospital with diagnosis of sepsis, and who require mechanical ventilation during hospitalization will be considered. Patients newly ventilated for at least one day but less than three days will be included in the study. Informed consent will be obtained from the legal authorized representative (LAR).
Mechanically ventilated septic patients admitted to the ICU receiving enteral and or parenteral nutrition will be randomly allocated to one of the aforementioned groups. Demographic information, parameters obtained from the ventilator, muscle measurements through ultrasonography, and clinical information, such as time spent on the mechanical ventilation, time spent in ICU and in the hospital will be collected. Participants will enroll in the study upon admission to the ICU until one of the following occurs-patient is extubated, discharged from the ICU, or death with a maximum of 14 days of ICU admission. Upon inclusion, IC will be assessed at baseline in all patients and then twice weekly. Bedside ultrasonography of the diaphragm and quadricep muscle thickness will be performed upon enrollment of the study (within 3 days of MV and within 1 day of study enrollment) and repeated every 3-5 days with a minimum of twice weekly while on the MV. Severity of illness score (APACHE IV), cause of sepsis, ventilator data, such as average tidal volumes and plateau pressures, cumulative and equivalent doses of sedatives (propofol, midazolam, lorazepam) and analgesics (fentanyl, hydromorphone) will be collected. Presence of delirium during ventilation, based on ICU-CAM scores will be included, as well.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients allocated to the measured energy expenditure (group M) will receive the intervention. Caloric delivery will target results of IC measurement.
Other: Caloric delivery will target results of IC measurement.
Patients allocated to the estimated energy expenditure (group E) will receive nutrition with caloric intake calculated based on the Penn State equation.
The prescribed calories to be delivered will be set to target the measurement obtained from performing indirect calorimetry (IC). IC measures the gas exchange of oxygen consumption and carbon dioxide production to determine the true metabolic needs for cellular respiration. The expenditure of calories will be measured utilizing the gas module incorporated within the General Electric Carescape R860 ventilators.
Ventilator free days (VFD)
The number of days from day 1 to day 28 (of hospital admission) on which the patient was not on the mechanical ventilator. If the patient expired or requires more than 28 days of mechanical ventilation, the value is zero.
Time frame: From current hospital admission date until the date of hospital discharge, date of death from any cause, whichever came first, assessed up to 28 days.
Calorie and protein adequacy
Nutritional adequacy of caloric and protein delivery is measured as a ratio of the calories and protein received by the patient compared to the calories and protein prescribed during mechanical ventilation. The ratios are determined individually for calories and protein.
Time frame: Nutritional adequacy will be assessed from day one of ventilation in all patients until extubation from the MV or date of death, whichever came first, assessed up to 14 days.
Change in quadricep muscle thickness
Evaluation of the change in muscle thickness during study enrollment in correlation with the adequacy of nutrition delivery.
Time frame: Quadricep muscle thickness will be measured upon enrollment to the study (within 72 hours of MV) and every 3-5 days with a minimum of two times per 7 days until extubation from the MV or date of death, whichever came first, assessed up to 14 days.
Change in diaphragm muscle thickness
Evaluation of the change in muscle thickness during study enrollment in correlation with the adequacy of nutrition delivery.
Time frame: Diaphragm muscle thickness will be measured upon enrollment to the study (within 72 hours of MV) and then every 3-5 days with a minimum of two times per 7 days until extubation from the MV or date of death, whichever came first, assessed up to 14 days.
Hospital Mortality
Expiration of the participant will be classified as "yes" if patient expired during the current hospital admission.
Time frame: From current hospital admission date until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 24 months.
Hospital length of stay
Total number of days patient was admitted to the hospital for the current admission.
Time frame: From current hospital admission date until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 24 months.
Intensive care unit length of stay
Total number of days patient was admitted in the intensive care unit for the current hospital admission.
Time frame: From current hospital admission date until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 24 months.
Plan to share: No
No publications or documents are linked to this record.
Ran from Sep 2018 to primary completion in May 2019, 8 months.
Of 301 non-industry interventional studies with no phase under Sepsis, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 42. This study's 8 months is below that.
Counting every sponsor, half of 324 studies reached it within 22 months; a quarter within 12 and three quarters within 40.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.
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