NCT05629780

Temporal Changes of Lactate in CLASSIC Patients

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 777 (actual)
• Sponsor: Karolinska University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Septic Shock

Interventions

Type	Name	Description
DRUG	Resuscitation fluid	Cristalloid fluids given as a resuscitational intervention

Timeline

• Start date: 2022-09-29
• Primary completion: 2022-12-28
• Completion: 2023-06-14
• First posted: 2022-11-29
• Last updated: 2023-09-14

Locations

1 site across 1 country: Sweden