Conservative vs. Liberal Approach to Fluid Therapy of Septic Shock in Intensive Care

• Status: Completed
• Trial end date: 2015-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this trial is to o assess feasibility of a protocol comparing conservative (trigger guided) vs. liberal (target guided) approach to fluid resuscitation in patients with septic shock after initial fluid resuscitation.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Anders Perner

Criteria

Inclusion Criteria:

• Adult intensive care patients (age ≥ 18 years) with sepsis defined as 2 of 4 SIRS criteria fulfilled within 24 hours and suspected or confirmed site of infection or positive blood culture.

• Suspected or confirmed circulatory impairment (hypotension/hypoperfusion/hypovolemia) for no more than 12 hours including the hours preceding ICU admission.

• At least 30 ml/kg ideal body weight (IBW) fluid (colloids, crystalloids or blood products) given in the last 6 hours.

• Shock defined as ongoing infusion of norepinephrine (any dose) to maintain blood pressure.

Exclusion Criteria:

• Use of any form of renal replacement therapy (RRT).

• RRT deemed imminent by the ICU doctor, i.e. RRT will be initiated within 6 hours.

• Severe hyperkalemia (p-K > 6 mM).

• Plasma creatinine > 350 µmol/l.

• Invasively ventilated with FiO2 > 0.80 and PEEP > 10 cmH2O

• Life-threatening bleeding.

• Kidney or liver transplant during current admission.

• Burns > 10% body surface area (BSA).

• Previously enrolled in the CLASSIC trial and has finished the 90 day observation period.

• Patients for whom it has been decided not to give full life support including mechanical ventilation and RRT.

• Consent not obtainable.