Conservative vs. Liberal Approach to Fluid Therapy of Septic Shock in Intensive Care (CLASSIC)
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ClinicalTrials.gov Identifier: NCT02079402 |
Recruitment Status :
Completed
First Posted : March 5, 2014
Last Update Posted : December 9, 2015
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Septic Shock Sepsis | Drug: Isotonic crystalloids | Phase 4 |

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 |
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:
Only isotonic crystalloids are to be given as resuscitation fluid; the type of isotonic crystalloid is free of choice. |
Drug: Isotonic crystalloids |
- Resuscitation volume [ Time Frame: 5 days after randomisation ]
- Resuscitation volume [ Time Frame: Followed up until ICU discharge; an expected average of one week ]
- Fluid balance [ Time Frame: 5 days after randomisation ]
- Fluid balance [ Time Frame: Followed up until ICU discharge; an expected average of one week ]
- Total fluid input [ Time Frame: 5 days after randomisation ]
- Total fluid input [ Time Frame: Followed up until ICU discharge; an expected average of one week ]
- 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.
- Accumulated serious adverse reactions (SARs) [ Time Frame: Followed up until ICU discharge; an expected average of one week ](SARs/length of ICU stay).
- All cause mortality [ Time Frame: 90 days after randomisation ]
- 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
- Days alive without use of mechanical ventilation [ Time Frame: in the 90 days from randomisation ](rate: 1-(days with event/days alive(1-90))
- 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))
- 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
- Ischaemic events [ Time Frame: Followed up until ICU discharge; an expected average of one week ]Yes/No
- 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

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

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
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 |
Principal Investigator: | Anders Perner, MD PhD | Rigshospitalet, Denmark |
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 |
sepsis septic shock ICU intensive critical |
resuscitation fluid IV crystalloid balance |
Shock, Septic Shock Sepsis Infection |
Systemic Inflammatory Response Syndrome Inflammation Pathologic Processes |