Bacterial SepsisNCT03343041
Study of Low Carbohydrate Enteral Nutrition in Patients With Bacterial Septic Shock
A study testing low-carbohydrate nutrition and Standard enteral nutrition in people with Bacterial Sepsis, run by Yale University at 1 site in United States.
Trial summary
This pilot study aims to test the tolerability of low-carbohydrate enteral nutrition in patients with bacterial septic shock. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Bacterial Sepsis
- What is being tested?
- low-carbohydrate nutrition and Standard enteral nutrition
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jan 2018to Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18-65 admitted to the MICU with a diagnosis of severe sepsis or septic shock
- Patients with 35 > BMI > 18.5
- Patients with serum pro-calcitonin > 1 ng/mL in the first 24 hours of hospitalization
Who cannot join
- Patients with chronic kidney disease as defined by glomerular filtration rate < 60 for > 6 months
- Patients with chronic liver disease as defined by radiographic or tissue evidence of cirrhosis or persistently abnormal liver function tests for > 6 months
- Patients with current malignancies
- Patients with autoimmune disease on current immunotherapy
- Patients on corticosteroids at doses of prednisone or prednisone-equivalents > 5 mg for > 6 months
- Patients with weight-reduction surgeries
- Patients with positive viral studies in the first 24 hours of admission
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale New Haven Hospital
New Haven, Connecticut, 06520
About this study
Official title: Pilot Study of Low-Carbohydrate Enteral Nutrition in Patients With Bacterial Septic Shock
This pilot study aims to test the tolerability of low-carbohydrate enteral nutrition in patients with bacterial septic shock.
Read the detailed description
This study seeks to assess the tolerability of utilizing low-carbohydrate nutrition in patients admitted to the MICU with bacterial septic shock. Low carbohydrate feeds have been used before in the critical care setting and were well-tolerated.
- Conditions
- Bacterial Sepsis
- Being tested
- low-carbohydrate nutrition, Standard enteral nutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low-carbohydrate nutritionDietary supplement
low-carbohydrate enteral nutrition
Standard enteral nutritionDietary supplement
standard enteral nutrition
| Study group | Role | What they receive |
|---|---|---|
| low carbohydrate nutrition | Active comparator | We will use a low-carbohydrate nutrition (LCN) formulated by the MICU registered dietitian and pharmacy staff, who routinely prepare enteral and parenteral nutrition which will provide:
5% carb, 41% protein, 54% lipid. Receives: Dietary Supplement: low-carbohydrate nutrition |
| standard enteral nutrition | Active comparator | The standard enteral nutrition (SEN) and per cent contribution of carbohydrates used in the Yale MICU is as follows:
Jevity 1.2 56% carb, 29.5% lipid, 18.5% protein Diabetisource 33% carb, 44% lipid, 20% protein Promote 55% carb, 25% lipid, 25% protein Vital AF 37% carb, 40% lipid, 25% protein Peptamin Intense 29% carb, 34% lipid, 37% protein Osmolite 1.5 54% carb, 29.5% lipid, 16.5% protein Receives: Dietary Supplement: Standard enteral nutrition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of stay (LOS) in the ICU.
The primary clinical outcome will be to reduce the length of stay (LOS) in the ICU. Average length of stay is 5 days.
Measured: discharge: average 5 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2017
- Study start8 Jan 2018
- Primary completionJan 2022 (estimated)
- Study completionJun 2022 (estimated)
Why it stopped: Covid and lack of resources
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bacterial SepsisStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The ultimate goal is to perform a prospective, single-center, double-blinded, parallel group, randomized, controlled trial on the safety and efficacy of low-carbohydrate enteral nutrition in adult patients admitted to the MICU with bacterial septic shock.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrew Wang, MD PhD, Principal investigator, Yale School of Medicine Department of Rheumatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03343041
- Sponsor's protocol ID
- 2000021424
- Status last verified
- Nov 2021
- First submitted
- 10 Nov 2017
- Last updated
- 26 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Low-Carbohydrate Enteral Nutrition in Patients With Bacterial Septic Shock
- ClinicalTrials.gov ID
- NCT03343041
- Acronym / sponsor ID
- 2000021424
- Conditions
- Bacterial Sepsis
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Covid and lack of resources
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- 8 Jan 2018 (actual)
- Primary completion
- Jan 2022 (estimated)
- Study completion
- Jun 2022 (estimated)
- First posted
- 17 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This pilot study aims to test the tolerability of low-carbohydrate enteral nutrition in patients with bacterial septic shock.
Detailed description
This study seeks to assess the tolerability of utilizing low-carbohydrate nutrition in patients admitted to the MICU with bacterial septic shock. Low carbohydrate feeds have been used before in the critical care setting and were well-tolerated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The ultimate goal is to perform a prospective, single-center, double-blinded, parallel group, randomized, controlled trial on the safety and efficacy of low-carbohydrate enteral nutrition in adult patients admitted to the MICU with bacterial septic shock.
| Arm | Type | Receives |
|---|---|---|
| low carbohydrate nutrition | Active comparator | Dietary Supplement: low-carbohydrate nutritionWe will use a low-carbohydrate nutrition (LCN) formulated by the MICU registered dietitian and pharmacy staff, who routinely prepare enteral and parenteral nutrition which will provide: 5% carb, 41% protein, 54% lipid. |
| standard enteral nutrition | Active comparator | Dietary Supplement: Standard enteral nutritionThe standard enteral nutrition (SEN) and per cent contribution of carbohydrates used in the Yale MICU is as follows: Jevity 1.2 56% carb, 29.5% lipid, 18.5% protein Diabetisource 33% carb, 44% lipid, 20% protein Promote 55% carb, 25% lipid, 25% protein Vital AF 37% carb, 40% lipid, 25% protein Peptamin Intense 29% carb, 34% lipid, 37% protein Osmolite 1.5 54% carb, 29.5% lipid, 16.5% protein |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients aged 18-65 admitted to the MICU with a diagnosis of severe sepsis or septic shock
- Patients with 35 > BMI > 18.5
- Patients with serum pro-calcitonin > 1 ng/mL in the first 24 hours of hospitalization
Key exclusion criteria (7 listed)
- Patients with chronic kidney disease as defined by glomerular filtration rate < 60 for > 6 months
- Patients with chronic liver disease as defined by radiographic or tissue evidence of cirrhosis or persistently abnormal liver function tests for > 6 months
- Patients with current malignancies
- Patients with autoimmune disease on current immunotherapy
- Patients on corticosteroids at doses of prednisone or prednisone-equivalents > 5 mg for > 6 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| low-carbohydrate nutritionlow-carbohydrate enteral nutrition | Dietary supplement | low carbohydrate nutrition |
| Standard enteral nutritionstandard enteral nutrition | Dietary supplement | standard enteral nutrition |
Primary outcome
Length of stay (LOS) in the ICU.
Time frame: discharge: average 5 days.
The primary clinical outcome will be to reduce the length of stay (LOS) in the ICU. Average length of stay is 5 days.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew Wang, MD PhD principal investigator
Yale School of Medicine Department of Rheumatology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing low-carbohydrate nutrition and Standard enteral nutrition in people with Bacterial Sepsis, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 26 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of stay (LOS) in the ICU. (time frame: discharge: average 5 days.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2021.