A Study of Different Ways to Use Intravenous Fluids (given through a vein) and Vasopressors (blood pressure medicine) for Sepsis

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Age: 18 years or older
Gender:
Any
Healthy Volunteers: No
Keywords: sepsis, septicemia, blood infection, septic shock
Type: Drug study, Phase 3
Target:
50 Participants
Investigator:
Description
This study will test different ways to use “intravenous fluids” (fluids given through a small tube placed in your vein). It will also test using “vasopressors” (medicines that raise blood pressure) to treat “sepsis,” (a serious infection).

We are asking you to be in this study because:
a) you have been diagnosed with low blood pressure due to an infection and
b) your blood pressure has stayed low after your doctors gave you fluids.

We do not know which approach is better in this situation:
a) starting medicines to raise blood pressure first and then giving more fluids (if needed), or
b) giving a larger amount of fluids first and then giving medicines to raise blood pressure if needed. Right now, the choice of approach is left to the doctors.

Some doctors use medicines to raise blood pressure followed by extra fluids. Others use extra fluids followed by medicines to raise blood pressure. Some doctors use a combination of the two. This treatment part of the study will last for 24 hours, and then we will follow you until you go back to where you live. We want to find out whether one of these approaches compared to the other can improve a patient’s chances of survival.
This study requires

Before entering the study, you received an amount of fluids through a tube placed in your vein.

After getting these fluids you will be put into one of the two study groups. You will be in that group for 24 hours.

One group will receive fluids first, followed by medications to raise blood pressure (if needed).

The other group will receive medications to raise blood pressure first, then fluids (if needed).

Both groups will receive the study treatment through a tube placed in the vein (IV).

After 24- hours, your doctor will decide how the medicine to raise blood pressure and fluids will be given (if they are still needed).

Who can participate

Inclusion criteria:

  • Age ≥ 18 years
  • A suspected or confirmed infection (broadly defined by administration or planned administration of antibiotics)
  • Sepsis-induced hypotension defined as systolic blood pressure < 100 mmHg or MAP < 65mmHg after a minimum of at least 1 liter of fluid (*Fluids inclusive of pre-hospital fluids; blood pressure must be below any known or reported pre-morbid baseline).

Exclusion criteria:

  • More than 4 hours elapsed since meeting inclusion criteria or 24 hours elapsed since admission to the hospital
  • Patient already received 3 liters of intravenous fluid (includes prehospital volumes)
  • Unable to obtain informed consent
  • Known pregnancy
  • Hypotension suspected to be due to non-sepsis cause (e.g. hemorrhagic shock)
  • Blood pressure is at known or reported baseline level
  • Severe Volume Depletion from an acute condition other than sepsis. In the judgment of the treating physician, the patient has an acute condition other than sepsis causing (or indicative) of *severe volume depletion; Examples include: Diabetic ketoacidosis, high volume vomiting or diarrhea, hyperosmolar hyperglycemic state, and nonexertional hyperthermia (heat stroke); severe is defined by the need for substantial intravenous fluid administration as part of routine clinical care
  • Pulmonary edema or clinical signs of new fluid overload (e.g. bilateral crackles, new oxygen requirement, new peripheral edema, fluid overload on chest x-ray)
  • Treating physician unwilling to give additional fluids as directed by the liberal protocol
  • Treating physician unwilling to use vasopressors as directed by the restrictive protocol.
  • Current or imminent decision to withhold most/all life-sustaining treatment; this does not exclude those patients committed to full support except cardiopulmonary resuscitation
  • Immediate surgical intervention planned such that study procedures could not be followed
  • Prior enrollment in this study
Benefits and risks of participating
BENEFITS:

We cannot promise any benefits to you as a result of taking part in this research study.


RISKS:

The study doctor will discuss the risks associated with taking part in this research study.
Compensation
You will not be paid to take part in this research study.
Resources
Schedule
Study duration and period
You will receive the study treatment for 24 hours. After 24-hours, your doctor will decide how the medicines will be given (if they are still needed).
Recruitment period
From Aug. 31, 2018
Location
UC Davis Medical Center
2315 Stockton Boulevard
Sacramento, CA 95817
Contact
Skyler Pearson
Research Topic
Conditions:
  • Septic Shock

Have any questions or want to learn more? Leave your contact details below and the research team will reach out to you.


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