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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02079402
Recruitment Status : Completed
First Posted : March 5, 2014
Last Update Posted : December 9, 2015
Sponsor:
Information provided by (Responsible Party):
Anders Perner, Scandinavian Critical Care Trials Group

Brief 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.

Condition or disease Intervention/treatment Phase
Septic Shock Sepsis Drug: Isotonic crystalloids Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 153 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Conservative vs. Liberal Approach to Fluid Therapy of Septic Shock in Intensive Care (CLASSIC) - a Randomised Clinical Trial
Study Start Date : September 2014
Actual Primary Completion Date : November 2015
Actual Study Completion Date : November 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock

Arm Intervention/treatment
Active Comparator: Liberal (target-guided) fluid resuscitation

Noradrenaline to MAP >= 65 mmHg.

Fluid boluses may be given as long as hemodynamic variables improve (dynamic or static variable(s) of choice). A fluid bolus is to be followed by evaluation of effect 30 minutes after the intervention at the latest.

'Variable(s) of choice' refers to the variable(s) used to assess hemodynamic improvement.

Only isotonic crystalloids are to be given as resuscitation fluid; the type of isotonic crystalloid is free of choice.

Drug: Isotonic crystalloids
Experimental: Conservative (trigger-guided) fluid resuscitation

Noradrenaline to MAP >= 65 mmHg.

A fluid bolus of 250-500 ml may be given followed by evaluation of effect 30 minutes after the intervention at the latest if one of the following occurs:

  • Plasma lactate concentration ≥ 4 mmol/l at point-of-care testing.
  • Severe hypotension (MAP < 50mmHg).
  • Mottling beyond edge of kneecap.
  • Severe oliguria (only in the first 2 hours after randomisation). Severe oliguria defined as urine output ≤ 0.1 ml/kg/hour IBW last hour.

Only isotonic crystalloids are to be given as resuscitation fluid; the type of isotonic crystalloid is free of choice.

Drug: Isotonic crystalloids



Primary Outcome Measures :
  1. Resuscitation volume [ Time Frame: 5 days after randomisation ]
  2. Resuscitation volume [ Time Frame: Followed up until ICU discharge; an expected average of one week ]

Secondary Outcome Measures :
  1. Fluid balance [ Time Frame: 5 days after randomisation ]
  2. Fluid balance [ Time Frame: Followed up until ICU discharge; an expected average of one week ]
  3. Total fluid input [ Time Frame: 5 days after randomisation ]
  4. Total fluid input [ Time Frame: Followed up until ICU discharge; an expected average of one week ]
  5. Number of patients with protocol violations [ Time Frame: Followed up until ICU discharge; an expected average of one week ]
    Major protocol violation defined as: One or more resuscitation fluid boluses given without fulfilment of one or more of the Classic-criteria in the conservative (Trigger-guided) group.

  6. Accumulated serious adverse reactions (SARs) [ Time Frame: Followed up until ICU discharge; an expected average of one week ]
    (SARs/length of ICU stay).


Other Outcome Measures:
  1. All cause mortality [ Time Frame: 90 days after randomisation ]
  2. All-cause mortality [ Time Frame: Total observation time (90 days from randomisation of last patient) ]
    Time to death with censoring on the date at 90 days after the last patient had been randomized

  3. Days alive without use of mechanical ventilation [ Time Frame: in the 90 days from randomisation ]
    (rate: 1-(days with event/days alive(1-90))

  4. Days alive without use of renal replacement therapy [ Time Frame: in the 90 days from randomisation ]
    (rate: 1-(days with event/days alive (1-90))

  5. Worsening of acute kidney injury according to KDIGO criteria [ Time Frame: in the 90 days from randomisation ]
    Worsening of acute kidney injury according to KDIGO criteria in the 90 days after randomisation as compared to baseline value, Y/N

  6. Ischaemic events [ Time Frame: Followed up until ICU discharge; an expected average of one week ]
    Yes/No

  7. Delta-creatinine [ Time Frame: Followed up until ICU discharge; an expected average of one week ]
    defined as highest p-creatinine during ICU stay minus most recent p-creatinine prior to randomisation



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02079402


Locations
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Denmark
Dept. of Anaesthesia and Intensive Care, Aalborg University Hospital, Denmark.
Aalborg, Denmark
Copenhagen University Hospital, Rigshospitalet
Copenhagen, Denmark, 2100
Dept. of Intensive Care, Herlev Hospital, Herlev, Denmark
Herlev, Denmark
Dept. of Intensive Care, Herning Hospital, Herning, Denmark
Herning, Denmark
Dept. of Intensive Care, Nordsjællands Hospital - Hillerød, Denmark.
Hillerød, Denmark
Dept. of Intensive Care, Holbæk Hospital, Holbæk, Denmark
Holbæk, Denmark
Dept. og Intensive Care, Holstebro Hospital, Denmark
Holstebro, Denmark
Dept. of Intensive Care, Randers Hospital, Denmark.
Randers, Denmark
Finland
Dept. of Intensive Care Medicine, Helsinki University Hospital, Helsinki, Finland.
Helsinki, Finland
Sponsors and Collaborators
Anders Perner
Investigators
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Principal Investigator: Anders Perner, MD PhD Rigshospitalet, Denmark

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Anders Perner, Chair, Scandinavian Critical Care Trials Group
ClinicalTrials.gov Identifier: NCT02079402    
Other Study ID Numbers: RH-ITA-005
2014-000902-37 ( EudraCT Number )
First Posted: March 5, 2014    Key Record Dates
Last Update Posted: December 9, 2015
Last Verified: December 2015
Keywords provided by Anders Perner, Scandinavian Critical Care Trials Group:
sepsis
septic
shock
ICU
intensive
critical
resuscitation
fluid
IV
crystalloid
balance
Additional relevant MeSH terms:
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Shock, Septic
Shock
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes