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Clinical trial

Temporal Changes in Plasma Lactate Concentration in Critically Ill Patients With Septic Shock Treated With Restrictive Compared to Standard Fluid Therapy

ID
Name
Dnr 2021-06283-02
Description
This study aim to examine if randomization to different treatment strategies had any effect on the time to normalization of lactate in intensive care patients treated for septic shock.
Trial arms
Trial start
2022-09-29
Estimated PCD
2022-12-28
Trial end
2023-06-14
Status
Completed
Treatment
Resuscitation fluid
Cristalloid fluids given as a resuscitational intervention
Arms:
Conservative
Size
777
Primary endpoint
Time to resolution of hyperlactemia
72 hours
Eligibility criteria
Inclusion Criteria: * Participation in CLASSIC trial in any of the participating centres Exclusion Criteria: * Lack of sufficient data for analysis
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This is a retrospective analysis of patients recruited to an interventional multicenter trial.', 'primaryPurpose': 'BASIC_SCIENCE', 'maskingInfo': {'masking': 'SINGLE', 'maskingDescription': 'All patients are included and analyzed for outcomes in the CLASSIC trial. The allocation and amount of fluids received for the included subjects are blinded for the investigator at the time point of analysis.', 'whoMasked': ['INVESTIGATOR']}}, 'enrollmentInfo': {'count': 777, 'type': 'ACTUAL'}}
Updated at
2023-09-14

1 organization

1 product

1 indication

Organization
Karolinska University Hospital
Product
Resuscitation fluid
Indication
Septic shock