Septic Shock Clinical Trial
Official title:
Early Metabolic Support as a Potential Solution to Multi-Organ Dysfunction Syndrome (MODS) During Severe Sepsis
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.
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.
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