Restrictive Intravenous Fluids Trial in Sepsis

Launched by RHODE ISLAND HOSPITAL · Apr 27, 2017

Keywords

ClinConnect Summary

Sepsis is one of the most common indications for intensive care unit admission world wide and the third leading cause of death in the United States. While IV fluid administration has been recognized as an important part of sepsis resuscitation for over 15 years, there is growing concern that overly aggressive IV fluid resuscitation may be harmful to patients with severe sepsis and septic shock.

The current standard of care for initial resuscitation is outlined in the 2016 Surviving Sepsis guidelines which recommends a 30mL/kg bolus of IV fluid for septic patients with hypotension (mean art...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• 1. The patients must be suspected by the treating physician to have sepsis causing their acute illness as exhibited by 2 or more of the following Systemic Inflammatory Response Syndrome (SIRS) criteria was well as a known or suspected infection at the time of screening:
• • 1. Temperature of \> 38 C or \< 36 C
• • 2. Heart rate of \> 90/min
• • 3. Respiratory rate of \> 20/min or PaCO2 \< 32 mm Hg
• • 4. White blood cell count \> 12000/mm3 or \< 4000/mm3 or \>10% immature bands.
• • 2. Since approximately 12% of patients ultimately diagnosed with sepsis do not meet SIRS criteria , SIRS negative patients will be eligible for the study if the treating physician makes a clinical diagnosis of severe sepsis or septic shock.
• • 3. Patients must be suspected of having severe sepsis or septic shock defined as refractory hypotension or a lactic acid\>4 at the time of enrollment. Refractory hypotension is defined as having a SBP \<90 or MAP \<65, for 15 minutes, following 1000 mL of IV fluid or a blood pressure maintained by vasopressor administration.
• • 4. Patients must have received less than 60ml/kg of intravenous fluid at time of study enrollment.
• Exclusion Criteria:
• • 1. Patients with a PRIMARY diagnosis of acute cerebral vascular event, acute coronary syndrome, acute pulmonary edema, status asthmaticus, active gastrointestinal bleeding, seizure, drug overdose, burn, trauma, requirement for immediate surgery, or undergoing extracorporeal membrane oxygenation.
• • 2. Patients who have a diagnosis of severe sepsis or septic shock and additionally have an active fluid wasting process such as extensive diarrhea, diabetes insipidus, cerebral salt wasting, or an osmotic diuresis.
• • 3. Patients who have a diagnosis of severe sepsis or septic shock who have a concurrent diagnosis of diabetic ketoacidosis, hyperosmolar non-ketotic hyperglycemia, or rhabdomyolysis.
• • 4. Patients who have received \>60 ml/kg of IVF resuscitation.
• • 5. Patient who are \<18 years old, pregnant, or incarcerated.