Septic ShockPhase 2NCT02885688
Early Metabolic Support as a Potential Solution to Multi-Organ Dysfunction Syndrome (MODS) During Severe Sepsis
A Phase 2 study testing Liquid Nutrition and Insulin Drip in people with Septic Shock, run by M.D. Anderson Cancer Center.
Trial summary
The goal of this clinical research study is to learn if adding liquid nutrition therapy that is given by vein to standard-of-care treatment for sepsis can help to control sepsis symptoms better than giving standard-of-care treatment alone. 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?
- Liquid Nutrition and Insulin Drip
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Oct 2016to Oct 2018
- Phase
- Phase 2
- 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
- All adult patients 18-years-old or greater
- Admitted to the adult medical intensive unit (MICU) of MD Anderson Cancer Center
- Diagnosis of Sepsis within 12 hours of MICU admission defined as: 1) Suspected or documented infection and 2) Acute increase of >/= 2 SOFA points (a proxy for organ dysfunction)
- Diagnosis of Septic Shock within 12 hours of MICU admission defined as meeting criteria for sepsis (see inclusion criteria C) in addition to the following: 1) Vasopressor therapy needed to elevate MAP >/= 65 mmg Hg and 2) Lactate > 2 mmol/L (18 mg/dL) after adequate fluid resuscitation
- Sequential Organ Failure Assessment (SOFA) score meeting the following requirements: 1) Cardiovascular SOFA >/= 2 and 2) Total SOFA score of less than 15
- Diagnosis of leukemia, lymphoma, or status post stem cell transplantation
- Patients in septic shock and not able to tolerate enteral nutrition above 70 percent of their daily nutritional caloric intake.
Who cannot join
- Children (patients < 18-years-old) of age are not admitted to the MICU but to the pediatric intensive care unit (PICU)
- Do Not Resuscitate (DNR), Comfort Care or Moribund
- Death expected within the next 24 hours
- Active Bleeding
- End-stage Renal Disease (ESRD)
- Chronic Liver Disease: Childs-Pugh Class C and/or Diagnosis of Cirrhosis
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- Tumor Lysis Syndrome
- Sulfite Allergy: Hepatamine contraindicated. More common in asthmatics. (Please note that this is NOT sulfa allergy and is NOT contraindicated in patients with sulfa allergy)
- Serum sodium concentration < 130 milliequivalent (mEq)/L or >150 mEq/L (Note: Once serum sodium levels are >/= 130 or </= 150 mEq/L within 12 hours after meeting inclusion criteria, the patient can then be considered for the study. This is only a temporary restriction.)
- Serum Creatinine level: SCr > 2.5 mg/dL (Note: Once serum creatinine levels are =/< 2.5 mg/dL within 12 hours after meeting inclusion criteria, the patient can then be considered for the study. This is only a temporary restriction.)
- 11) Urine output < 400 cc/24hrs (Note: Once urine output levels are >/= 400 cc within 12 hours after meeting inclusion criteria, the patient can then be considered for the study. This is only a temporary restriction.)
- Hyperkalemia K > 5.5 mEq/L (Note: Once potassium levels are </= 5.5 mEq/L within 12 hours after meeting inclusion criteria, the patient can then be considered for the study. This is only a temporary restriction.)
- Hyperglycemia: Glucose > 250 mg/dL (Note: Once glucose is </= 250 mg/dL within 12 hours after meeting inclusion criteria, the patient can then be considered for the study. This is only a temporary restriction.)
- Hyperphosphatemia: Serum Phosphorous > 8.0 mg/dL
- Patient with a history of metabolic abnormality in any one of the following amino acids: Alanine, Arginine, Cysteine hydrochloride, Glycine, Histidine, Isoleucine, Leucine, Lysine acetate, Methionine, Phenylalanine, Phosphoric ac-id, Proline, Serine, Threonine, Tryptophan, and Valine.
About this study
The goal of this clinical research study is to learn if adding liquid nutrition therapy that is given by vein to standard-of-care treatment for sepsis can help to control sepsis symptoms better than giving standard-of-care treatment alone.
Researchers also want to compare the length of ICU and hospital stay and any side effects between these 2 treatments.
Read the detailed description
Study Groups and Procedures:
If participant is eligible and chooses to take part in this study, they will be randomly assigned (as in the flip of a coin) to 1 of 2 study groups. This is done because no one knows if one study group is better, the same, or worse than the other group.
Group 1 will receive standard-of-care treatment alone for up to 7 days.
Group 2 will receive standard treatment for up to 7 days, plus liquid nutrition. The liquid nutrition will be given by vein non-stop for up to 7 days. The liquid nutrition therapy may stop sooner if participant's doctor thinks they are ready, based on how they are tolerating tube feeding.
Both Groups: As part of standard treatment, participants will receive breathing and blood pressure support, daily routine blood draws, imaging, standard drugs (such as antibiotics and blood pressure drugs), and other tests the doctor decides are needed. These tests and treatment will begin within 12 hours after participant is admitted to the ICU.
Participant's doctor will discuss the standard treatment and tests with them in more detail. Participant may ask the study staff for information about how the standard treatment and tests are given and their risks.
If participant is in Group 2, blood (about 4 teaspoons) will be drawn on Days 1-7 to check their blood oxygen and sugar levels. These tests may help the doctor make any needed changes to participant's liquid nutrition therapy.
Length of Participation:
Participant will take part in this study for up to 7 days. Patient's participation on this study will be over after Day 7 or when they can leave the ICU, whichever happens first. Participant may be taken off study early if intolerable side effects occur or if they are unable to follow study directions.
This is an investigational study. The liquid nutrition provided in this study is FDA approved and commercially available. Comparing the 2 study groups is investigational. The study doctor can explain how the liquid nutrition is designed to work.
Up to 50 participants will be enrolled in this study. All will take part at MD Anderson.
- Conditions
- Septic Shock
- Being tested
- Liquid Nutrition, Insulin Drip
- Keywords
- Septic Shock, Sepsis, Standard of care, Liquid nutrition, Metabolic support, Enteral nutrition, Insulin Drip, Glucose Drip
- Medical subject headings
- Shock, Septic, Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liquid NutritionDietary supplement
Also called Metabolic support, Enteral nutrition
Participants receive liquid nutrition by vein non-stop for up to 7 days.
Insulin DripProcedure or surgery
Also called Glucose Drip
Insulin drip by vein to keep serum glucose level between 140 and 180 mg/dL as per ICU protocol.
The interventions required in the current standard management of patients with septic shock is based on the MD Anderson Evidence-Based Protocol (EBP) for management of Severe Sepsis initiated on admission to the ICU.
| Study group | Role | What they receive |
|---|---|---|
| Standard-of-Care Treatment for Sepsis | Other | Participants with diagnosis of septic shock in MD Anderson Cancer Center ICU receive standard of care treatment alone for up to 7 days. Receives: Procedure: Insulin Drip |
| Standard-of-Care Treatment Plus Liquid Nutrition for Sepsis | Experimental | Participants with diagnosis of septic shock in MD Anderson Cancer Center ICU receive standard of care treatment plus plus liquid nutrition for up to 7 days. Receives: Dietary Supplement: Liquid Nutrition; Procedure: Insulin Drip |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of Early Metabolic Support in Participants with Sepsis Determined by Accrual
Trial feasible if ≥ 50% of eligible patients consent (i.e., approach 100 patients to achieve 50 that consent).
Measured: 7 days
Feasibility of Early Metabolic Support in Participants with Sepsis Determined by Adherence
Trial feasible if ≥ 60% of enrolled patients complete the treatments up to 7 days or upon discharge from the ICU, whichever comes first.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2016 (estimated)
- Study startOct 2016
- Primary completionOct 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Septic ShockStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe 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 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Diego de Villalobos, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02885688
- Sponsor's protocol ID
- 2015-1014
- Status last verified
- Feb 2017
- First submitted
- 17 Aug 2016
- Last updated
- 24 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Metabolic Support as a Potential Solution to Multi-Organ Dysfunction Syndrome (MODS) During Severe Sepsis
- ClinicalTrials.gov ID
- NCT02885688
- Acronym / sponsor ID
- 2015-1014
- Conditions
- Septic Shock
- Keywords
- Septic Shock, Sepsis, Standard of care, Liquid nutrition, Metabolic support, Enteral nutrition, Insulin Drip, Glucose Drip
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- Oct 2018 (estimated)
- First posted
- 31 Aug 2016 (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.
The goal of this clinical research study is to learn if adding liquid nutrition therapy that is given by vein to standard-of-care treatment for sepsis can help to control sepsis symptoms better than giving standard-of-care treatment alone.
Researchers also want to compare the length of ICU and hospital stay and any side effects between these 2 treatments.
Detailed description
Study Groups and Procedures:
If participant is eligible and chooses to take part in this study, they will be randomly assigned (as in the flip of a coin) to 1 of 2 study groups. This is done because no one knows if one study group is better, the same, or worse than the other group.
Group 1 will receive standard-of-care treatment alone for up to 7 days.
Group 2 will receive standard treatment for up to 7 days, plus liquid nutrition. The liquid nutrition will be given by vein non-stop for up to 7 days. The liquid nutrition therapy may stop sooner if participant's doctor thinks they are ready, based on how they are tolerating tube feeding.
Both Groups: As part of standard treatment, participants will receive breathing and blood pressure support, daily routine blood draws, imaging, standard drugs (such as antibiotics and blood pressure drugs), and other tests the doctor decides are needed. These tests and treatment will begin within 12 hours after participant is admitted to the ICU.
Participant's doctor will discuss the standard treatment and tests with them in more detail. Participant may ask the study staff for information about how the standard treatment and tests are given and their risks.
If participant is in Group 2, blood (about 4 teaspoons) will be drawn on Days 1-7 to check their blood oxygen and sugar levels. These tests may help the doctor make any needed changes to participant's liquid nutrition therapy.
Length of Participation:
Participant will take part in this study for up to 7 days. Patient's participation on this study will be over after Day 7 or when they can leave the ICU, whichever happens first. Participant may be taken off study early if intolerable side effects occur or if they are unable to follow study directions.
This is an investigational study. The liquid nutrition provided in this study is FDA approved and commercially available. Comparing the 2 study groups is investigational. The study doctor can explain how the liquid nutrition is designed to work.
Up to 50 participants will be enrolled in this study. All will take part at MD Anderson.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard-of-Care Treatment for Sepsis | Other | Procedure: Insulin DripParticipants with diagnosis of septic shock in MD Anderson Cancer Center ICU receive standard of care treatment alone for up to 7 days. |
| Standard-of-Care Treatment Plus Liquid Nutrition for Sepsis | Experimental | Dietary Supplement: Liquid Nutrition, Procedure: Insulin DripParticipants with diagnosis of septic shock in MD Anderson Cancer Center ICU receive standard of care treatment plus plus liquid nutrition for up to 7 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- All adult patients 18-years-old or greater
- Admitted to the adult medical intensive unit (MICU) of MD Anderson Cancer Center
- Diagnosis of Sepsis within 12 hours of MICU admission defined as: 1) Suspected or documented infection and 2) Acute increase of >/= 2 SOFA points (a proxy for organ dysfunction)
- Diagnosis of Septic Shock within 12 hours of MICU admission defined as meeting criteria for sepsis (see inclusion criteria C) in addition to the following: 1) Vasopressor therapy needed to elevate MAP >/= 65 mmg Hg and 2) Lactate > 2 mmol/L (18 mg/dL) after adequate fluid resuscitation
- Sequential Organ Failure Assessment (SOFA) score meeting the following requirements: 1) Cardiovascular SOFA >/= 2 and 2) Total SOFA score of less than 15
Key exclusion criteria (15 listed)
- Children (patients < 18-years-old) of age are not admitted to the MICU but to the pediatric intensive care unit (PICU)
- Do Not Resuscitate (DNR), Comfort Care or Moribund
- Death expected within the next 24 hours
- Active Bleeding
- End-stage Renal Disease (ESRD)
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 |
|---|---|---|
| Liquid NutritionAlso: Metabolic support, Enteral nutritionParticipants receive liquid nutrition by vein non-stop for up to 7 days. | Dietary supplement | Standard-of-Care Treatment Plus Liquid Nutrition for Sepsis |
| Insulin DripAlso: Glucose DripInsulin drip by vein to keep serum glucose level between 140 and 180 mg/dL as per ICU protocol. The interventions required in the current standard management of patients with septic shock is based on the MD Anderson Evidence-Based Protocol (EBP) for management of Severe Sepsis initiated on admission to the ICU. | Procedure or surgery | Standard-of-Care Treatment Plus Liquid Nutrition for Sepsis, Standard-of-Care Treatment for Sepsis |
Primary outcome
Feasibility of Early Metabolic Support in Participants with Sepsis Determined by Accrual
Time frame: 7 days
Trial feasible if ≥ 50% of eligible patients consent (i.e., approach 100 patients to achieve 50 that consent).
Feasibility of Early Metabolic Support in Participants with Sepsis Determined by Adherence
Time frame: 7 days
Trial feasible if ≥ 60% of enrolled patients complete the treatments up to 7 days or upon discharge from the ICU, whichever comes first.
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 24 Feb 2017.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
Related trials for Septic Shock
Not yet recruitingObservational study
Serum GDF-15 and LGALS3BP as Prognostic Biomarkers in Sepsis
Sepsis, Septic Shock
RecruitingPhase 3
A Trial of Adjunctive Fludrocortisone (50mcg, 100mcg or Placebo) in Critically Ill Patients With Septic Shock Receiving Hydrocortisone, Evaluating Survival and Functional Recovery and the Influence of Transcriptomic Response
Septic Shock
Recruiting
Veno-arterial Carbon Dioxide Partial Pressure Difference (CO2gap) for Early Resuscitation of Septic Shock
Sepsis - to Reduce Mortality in the Intensive Care Unit, Septic Shock
Not yet recruiting
Hemodynamic Resuscitation Guided by Non-Invasive Mean Systemic Filling Pressure to Prevent Acute Kidney Injury in Septic Shock
Acute Kidney Injury Due to Sepsis
RecruitingObservational study
Clinical Value of EMR3 in Sepsis Diagnosis, Monitoring, and Prognosis: A Multicenter Prospective Observational Study
Sepsis
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.
Diego de Villalobos, MD principal investigator
M.D. Anderson Cancer Center
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Liquid Nutrition and Insulin Drip in people with Septic Shock, run by M.D. Anderson Cancer Center.
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 7 inclusion and 15 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 24 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Feasibility of Early Metabolic Support in Participants with Sepsis Determined by Accrual (time frame: 7 days). The study lists 2 primary outcomes in all. 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 24 Feb 2017.