Temporal Changes of Lactate in CLASSIC Patients

Karolinska University Hospital

Status: Completed

Conditions: Septic Shock

Treatments: Drug: Resuscitation fluid

Study type: Interventional

Funder types: Other

Identifiers

NCT05629780

Dnr 2021-06283-02

Details and patient eligibility

About

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.

Full description

This is a retrospective analysis of a subset of patients included in the Conservative versus Liberal Approach to fluid therapy of Septic Shock in Intensive Care (CLASSIC) trial.

In the CLASSIC trial patients with septic shock were randomized to either traditional (liberal) strategy for fluid treatment or a more conservative regimen. The study was an international multicenter clinical trial (clinicaltrials.gov NCT03668236), and results were published in New England Journal of Medicine in June 2022 (DOI: 10.1056/NEJMoa2202707).

In this substudy the investigator extract all lactate values for the study period from all patients included from Karolinska University Hospital, Sundsvall and Södersjukhuset (Sweden), participating centers on Zealand (Denmark), and Plzen University Hospital (Czech Republic). Baseline data, treatment allocation and amount of fluids administered are collected as well as outcome from CLASSIC study.

Primary outcome is time to lactate normalization (< 2mmol/L). Secondary outcome is lactate concentration over the first 72 hours (as peak lactate for the time intervals 0-3, 3-6, 6-12, 12-24 and then each 12h-period between 24 and 72 hours).

The subgroup with blood lactate > 4mmol/L will be analyzed separately for the same end points.

Time to resolution of hyperlactatemia will be modelled with a competing risks regression. Death and discharge will be competing outcomes, and administrative censoring imposed 72 hours after randomisation.

Factors associated with time to lactate normalization will be examined through regression analysis. Factors that show a relationship on univariate analysis will be included in a multivariate analysis.

Enrollment: 777 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participation in CLASSIC trial in any of the participating centres

Exclusion criteria

• Lack of sufficient data for analysis

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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777 participants in 2 patient groups

Conservative

Experimental group

Description:

Resuscitation fluids were only given under certain pre-defined criteria

Treatment:

Drug: Resuscitation fluid

Traditional (liberal)

No Intervention group

Description:

Patients were treated with standard of care for each site with regards to recuscitation fluids.