Conservative vs. Liberal Approach to fluid therapy of Septic Shock in Intensive Care

Conditions: Septic shock
MedDRA version: 17.0Level: LLTClassification code 10040050Term: Sepsis NOSSystem Organ Class: 100000004862
Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

Registration Number: EUCTR2014-000902-37-DK

Lead Sponsor: Dept. of Intensive Care, Copenhagen University Hospital, Rigshospitalet

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 150

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
AND
Suspected or confirmed circulatory impairment (hypotension/hypoperfusion/hypovolemia) for at least 6 hours and no more than 12 hours including the hours preceding ICU admission
AND
At least 30 ml/kg IBW fluid (colloids, crystalloids or blood products) given in the last 6 hours
AND
Shock (defined as ongoing infusion of norepinephrine (any dose) to maintain blood pressure)

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 70
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 80

Exclusion Criteria

Use of any form of renal replacement therapy (RRT) or 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 mmHg.
Life-threatening bleeding.
Kidney or liver transplant during current admission.
Burns > 10% BSA.
Previously enrolled in the CLASSIC trial and has finished the 90 day observation period
Withdrawal of active therapypatients for whom it has been decided not to give full life support including mechanical ventilation and RRT.
Consent not obtainable.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: to assess the feasibility of a trial comparing two approaches to fluid resuscitation of septic shock after initial resuscitation; a trigger guided approach vs. a target guided approach, the latter reflecting standard care;Secondary Objective: Not applicable;Primary end point(s): 1.Amount of resuscitation fluid given in the first 5 days after randomisation;Timepoint(s) of evaluation of this end point: day 5 after randomisation

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Secondary outcomes:<br>2.1Amount of resuscitation fluid given during ICU stay<br>2.2Fluid balance and total fluid input at day 5 after randomisation and during ICU stay<br>2.3Number of patients with major protocol violations <br>2.4Accumulated serious adverse reactions (SARs) in ICU<br>Exploratory outcomes:<br>a.All-cause mortality at day 90<br>b.Mortality during the total observation time<br>c.Days alive without use of mechanical ventilation<br>d.Days alive without use of RRT<br>e.Worsening of acute kidney injury according to KDIGO criteria during ICU stay<br>f.Delta-creatinine (defined as highest p-creatinine during ICU stay minus most recent p-creatinine prior to randomisation)<br>g.Ischaemic events in ICU. <br>;Timepoint(s) of evaluation of this end point: day 5 after randomisation, ICU discharge or 90 days after randomisation