Restrictive Intravenous Fluids Trial in Sepsis

Completed · Not applicable

Conditions studied: Septic Shock, Severe Sepsis

In brief

IV fluid resuscitation has long been recognized to be an important treatment for patients with severe sepsis and septic shock. While under-resuscitation is known to increase morbidity and mortality, contemporary data suggests that overly aggressive fluid resuscitation may also be harmful. Currently, following an initial IVF resuscitation of 30 ml/kg, there is no standard of care and a lack of evidence to support a fluid restrictive or more liberal strategy. The investigators seek to determine if a fluid restrictive strategy reduces morbidity and mortality among patients with severe sepsis and septic shock.

Key facts

Study ID

NCT03137446

Run by

Rhode Island Hospital

People needed

113

Starts

2017-04-20

Expected to finish

2018-03-30

Last updated by the study team

2018-08-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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:
• Temperature of > 38 C or < 36 C
• Heart rate of > 90/min
• Respiratory rate of > 20/min or PaCO2 < 32 mm Hg
• White blood cell count > 12000/mm3 or < 4000/mm3 or >10% immature bands.
• 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.
• 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.
• Patients must have received less than 60ml/kg of intravenous fluid at time of study enrollment.

You may not qualify if…

• 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.
• 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.
• 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.
• Patients who have received >60 ml/kg of IVF resuscitation.
• Patient who are <18 years old, pregnant, or incarcerated.

Where it is running

• Rhode Island Hosptial — Providence, Rhode Island, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.