Septic ShockNCT02025127
A Randomized Controlled Study of Enteral Nutrition in Septic Shock
A study testing Enteral nutrition in people with Septic Shock, run by Medical College of Wisconsin at 1 site in United States.
Trial summary
There is a paucity of data on the timing and role of enteral nutrition in septic shock. The primary aim of this study is to conduct a phase III single-center pilot randomized controlled trial comparing early trophic enteral nutrition to 'no enteral nutrition' in mechanically ventilated septic shock patients to… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Septic Shock
- What is being tested?
- Enteral nutrition
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to Jan 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults greater than or equal to 18 years old
- Clinical diagnosis of septic shock
- Mechanically ventilation anticipated for at least 48 hours
Who cannot join
- Do not resuscitate order
- Not able to obtain consent
- Those not able to be randomized within 18 hours
- Those with small bowel ischemia or obstruction
- Protracted ileus, intractable vomiting, major gastrointestinal bleeding defined as needing 2 or more units of packed red cells, and any bowel surgery within the previous 30 days prior to intensive care unit admission
- Those with a contraindication for placement of a feeding tube
Trial locations and contacts
1 site in 1 country.
About this study
There is a paucity of data on the timing and role of enteral nutrition in septic shock.
The primary aim of this study is to conduct a phase III single-center pilot randomized controlled trial comparing early trophic enteral nutrition to 'no enteral nutrition' in mechanically ventilated septic shock patients to determine feasibility.
Read the detailed description
Septic shock represents the body's dysregulated response to an infection, manifesting as persistent hypotension (mean arterial pressure < 70 mmHg) despite intravenous (IV) fluid resuscitation. Severe sepsis and septic shock are major healthcare problems, affecting millions of people around the world each year In critically ill patients without shock, provision of enteral nutrition within 24-48 hours has shown to preserve intestinal epithelium, maintain brush border enzyme activity, maintenance of barrier function to enhance immune function, and preservation of tight cell junctions to reduce permeability. These benefits of enteral nutrition are postulated to prevent downstream complications of nosocomial infections and the multiple organ dysfunction syndrome (MODS), though direct data addressing this question are lacking.
The primary aim of this study is to conduct a phase III single-center pilot randomized controlled trial comparing early trophic EN to 'no EN' in mechanically ventilated septic shock patients to determine feasibility of achieving >75% consent and compliance rate and <10% contamination rate.
- Conditions
- Septic Shock
- Being tested
- Enteral nutrition
- Keywords
- septic shock, mechanical ventilation, enteral nutrition, trophic feeding
- Medical subject headings
- Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enteral nutritionOther
Enteral nutrition introduced via a feeding tube
| Study group | Role | What they receive |
|---|---|---|
| Trophic feeding | Experimental | Mechanically ventilated patients with septic shock > 18 years old randomized to this group will receive more than 50 but less than 600 kilocalories of enteral nutrition per day while on vasopressors. This will be started within 24 hours of intensive care unit admission. Receives: Other: Enteral nutrition |
| No Enteral Nutrition | No intervention | Mechanically ventilated patients with septic shock randomized to this group will receive no enteral nutrition while on vasopressor support. |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of patients consenting to study and remaining compliant with assigned study arm
consent and compliance rate of >75% and contamination rate <10%
Measured: 46 months
Secondary outcomes (4)
Ventilator free days
Number of days alive and off mechanical ventilatory support out of 30
Measured: 30 days
Hospital mortality
number of patients who died during hospitalization
Measured: 30 days
intensive care unit free days
number of days alive and out of the intensive care unit out of 30
Measured: 30 days
change in 48 hour sequential organ failure assessment score, with higher score representing worse outcome
absolute change in sequential organ failure assessment score (range 0-24 points) from day 0 to 48 hours, with higher scores representing worse outcomes
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2013 (estimated)
- Study startJan 2014
- Primary completionJan 2018
- Study completionJan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Septic ShockStudies of the same condition, open and under way.
- More trials run by Medical College of WisconsinThe 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
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jayshil J. Patel, MD, Medical College of Wisconsin
- Investigators
- Jayshil J Patel, MD, Principal investigator, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02025127
- Sponsor's protocol ID
- 19966
- Status last verified
- Aug 2019
- First submitted
- 17 Dec 2013
- Last updated
- 16 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Annane D, Bellissant E, Cavaillon JM. Septic shock. Lancet. 2005 Jan 1-7;365(9453):63-78. doi: 10.1016/S0140-6736(04)17667-8.
PubMed 15639681Dellinger RP, Levy MM, Rhodes A, Annane D, Gerlach H, Opal SM, Sevransky JE, Sprung CL, Douglas IS, Jaeschke R, Osborn TM, Nunnally ME, Townsend SR, Reinhart K, Kleinpell RM, Angus DC, Deutschman CS, Machado FR, Rubenfeld GD, Webb S, Beale RJ, Vincent JL, Moreno R; Surviving Sepsis Campaign Guidelines Committee including The Pediatric Subgroup. Surviving Sepsis Campaign: international guidelines for management of severe sepsis and septic shock, 2012. Intensive Care Med. 2013 Feb;39(2):165-228. doi: 10.1007/s00134-012-2769-8. Epub 2013 Jan 30.
PubMed 23361625McClave SA, Martindale RG, Vanek VW, McCarthy M, Roberts P, Taylor B, Ochoa JB, Napolitano L, Cresci G; A.S.P.E.N. Board of Directors; American College of Critical Care Medicine; Society of Critical Care Medicine. 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.). JPEN J Parenter Enteral Nutr. 2009 May-Jun;33(3):277-316. doi: 10.1177/0148607109335234. No abstract available.
PubMed 19398613Cresci G, Cue J. The patient with circulatory shock: to feed or not to feed? Nutr Clin Pract. 2008 Oct-Nov;23(5):501-9. doi: 10.1177/0884533608323431.
PubMed 18849555Revelly JP, Tappy L, Berger MM, Gersbach P, Cayeux C, Chiolero R. Early metabolic and splanchnic responses to enteral nutrition in postoperative cardiac surgery patients with circulatory compromise. Intensive Care Med. 2001 Mar;27(3):540-7. doi: 10.1007/s001340100855.
PubMed 11355123Khalid I, Doshi P, DiGiovine B. Early enteral nutrition and outcomes of critically ill patients treated with vasopressors and mechanical ventilation. Am J Crit Care. 2010 May;19(3):261-8. doi: 10.4037/ajcc2010197.
PubMed 20436064Bone RC, Balk RA, Cerra FB, Dellinger RP, Fein AM, Knaus WA, Schein RM, Sibbald WJ. Definitions for sepsis and organ failure and guidelines for the use of innovative therapies in sepsis. The ACCP/SCCM Consensus Conference Committee. American College of Chest Physicians/Society of Critical Care Medicine. Chest. 1992 Jun;101(6):1644-55. doi: 10.1378/chest.101.6.1644.
PubMed 1303622
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Study of Enteral Nutrition in Septic Shock
- ClinicalTrials.gov ID
- NCT02025127
- Acronym / sponsor ID
- 19966
- Conditions
- Septic Shock
- Keywords
- septic shock, mechanical ventilation, enteral nutrition, trophic feeding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Jan 2018 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 31 Dec 2013 (estimated)
- 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.
There is a paucity of data on the timing and role of enteral nutrition in septic shock.
The primary aim of this study is to conduct a phase III single-center pilot randomized controlled trial comparing early trophic enteral nutrition to 'no enteral nutrition' in mechanically ventilated septic shock patients to determine feasibility.
Detailed description
Septic shock represents the body's dysregulated response to an infection, manifesting as persistent hypotension (mean arterial pressure < 70 mmHg) despite intravenous (IV) fluid resuscitation. Severe sepsis and septic shock are major healthcare problems, affecting millions of people around the world each year In critically ill patients without shock, provision of enteral nutrition within 24-48 hours has shown to preserve intestinal epithelium, maintain brush border enzyme activity, maintenance of barrier function to enhance immune function, and preservation of tight cell junctions to reduce permeability. These benefits of enteral nutrition are postulated to prevent downstream complications of nosocomial infections and the multiple organ dysfunction syndrome (MODS), though direct data addressing this question are lacking.
The primary aim of this study is to conduct a phase III single-center pilot randomized controlled trial comparing early trophic EN to 'no EN' in mechanically ventilated septic shock patients to determine feasibility of achieving >75% consent and compliance rate and <10% contamination rate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Trophic feeding | Experimental | Other: Enteral nutritionMechanically ventilated patients with septic shock > 18 years old randomized to this group will receive more than 50 but less than 600 kilocalories of enteral nutrition per day while on vasopressors. This will be started within 24 hours of intensive care unit admission. |
| No Enteral Nutrition | No intervention | –Mechanically ventilated patients with septic shock randomized to this group will receive no enteral nutrition while on vasopressor support. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults greater than or equal to 18 years old
- Clinical diagnosis of septic shock
- Mechanically ventilation anticipated for at least 48 hours
Key exclusion criteria (6 listed)
- Do not resuscitate order
- Not able to obtain consent
- Those not able to be randomized within 18 hours
- Those with small bowel ischemia or obstruction
- Protracted ileus, intractable vomiting, major gastrointestinal bleeding defined as needing 2 or more units of packed red cells, and any bowel surgery within the previous 30 days prior to intensive care unit admission
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 |
|---|---|---|
| Enteral nutritionEnteral nutrition introduced via a feeding tube | Other | Trophic feeding |
Primary outcome
number of patients consenting to study and remaining compliant with assigned study arm
Time frame: 46 months
consent and compliance rate of >75% and contamination rate <10%
4 secondary outcomes
Ventilator free days
Time frame: 30 days
Hospital mortality
Time frame: 30 days
intensive care unit free days
Time frame: 30 days
change in 48 hour sequential organ failure assessment score, with higher score representing worse outcome
Time frame: 48 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2019.
- Background: PubMed 15639681Annane D, Bellissant E, Cavaillon JM. Septic shock. Lancet. 2005 Jan 1-7;365(9453):63-78. doi: 10.1016/S0140-6736(04)17667-8.
- Background: PubMed 23361625Dellinger RP, Levy MM, Rhodes A, Annane D, Gerlach H, Opal SM, Sevransky JE, Sprung CL, Douglas IS, Jaeschke R, Osborn TM, Nunnally ME, Townsend SR, Reinhart K, Kleinpell RM, Angus DC, Deutschman CS, Machado FR, Rubenfeld GD, Webb S, Beale RJ, Vincent JL, Moreno R; Surviving Sepsis Campaign Guidelines Committee including The Pediatric Subgroup. Surviving Sepsis Campaign: international guidelines for management of severe sepsis and septic shock, 2012. Intensive Care Med. 2013 Feb;39(2):165-228. doi: 10.1007/s00134-012-2769-8. Epub 2013 Jan 30.
- Background: PubMed 19398613McClave SA, Martindale RG, Vanek VW, McCarthy M, Roberts P, Taylor B, Ochoa JB, Napolitano L, Cresci G; A.S.P.E.N. Board of Directors; American College of Critical Care Medicine; Society of Critical Care Medicine. 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.). JPEN J Parenter Enteral Nutr. 2009 May-Jun;33(3):277-316. doi: 10.1177/0148607109335234. No abstract available.
- Background: PubMed 18849555Cresci G, Cue J. The patient with circulatory shock: to feed or not to feed? Nutr Clin Pract. 2008 Oct-Nov;23(5):501-9. doi: 10.1177/0884533608323431.
- Background: PubMed 11355123Revelly JP, Tappy L, Berger MM, Gersbach P, Cayeux C, Chiolero R. Early metabolic and splanchnic responses to enteral nutrition in postoperative cardiac surgery patients with circulatory compromise. Intensive Care Med. 2001 Mar;27(3):540-7. doi: 10.1007/s001340100855.
- Background: PubMed 20436064Khalid I, Doshi P, DiGiovine B. Early enteral nutrition and outcomes of critically ill patients treated with vasopressors and mechanical ventilation. Am J Crit Care. 2010 May;19(3):261-8. doi: 10.4037/ajcc2010197.
- Background: PubMed 1303622Bone RC, Balk RA, Cerra FB, Dellinger RP, Fein AM, Knaus WA, Schein RM, Sibbald WJ. Definitions for sepsis and organ failure and guidelines for the use of innovative therapies in sepsis. The ACCP/SCCM Consensus Conference Committee. American College of Chest Physicians/Society of Critical Care Medicine. Chest. 1992 Jun;101(6):1644-55. doi: 10.1378/chest.101.6.1644.
- Individual participant dataSharing planned: No
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Septic Shock
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.
Jayshil J Patel, MD principal investigator
Medical College of Wisconsin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enteral nutrition in people with Septic Shock, run by Medical College of Wisconsin 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 6 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: finished, as of the sponsor's last update on 16 Aug 2019. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
number of patients consenting to study and remaining compliant with assigned study arm (time frame: 46 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02025127, which also lists 7 linked publications.
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 16 Aug 2019; AzTrials last refreshed its copy on 7 Nov 2026.