Temporal Changes of Lactate in CLASSIC Patients

Septic Shock Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05629780
• Other study ID #: Dnr 2021-06283-02
• Status: Completed
• Phase: N/A
• Start date: September 29, 2022
• Est. completion date: June 14, 2023

Study information

• Verified date: September 2023
• Source: Karolinska University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 777
• Est. completion date: June 14, 2023
• Est. primary completion date: December 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Participation in CLASSIC trial in any of the participating centres

Exclusion Criteria:

• Lack of sufficient data for analysis

Related Conditions & MeSH terms

• Septic Shock
• Shock, Septic

Intervention

Drug:
• Resuscitation fluid
Cristalloid fluids given as a resuscitational intervention

Locations

Country	Name	City	State
Sweden	Karolinska University Hospital	Stockholm

Sponsors (5)

Lead Sponsor	Collaborator
Karolinska University Hospital	Collabortation for Research in Intensive Care (CRIC), European Society of Intensive Care Medicine, Region Stockholm, The Scandinavian Society of Anaesthesiology and Intensive Care Medicine (SSAI)

Country where clinical trial is conducted

Sweden, 

References & Publications (1)

Meyhoff TS, Hjortrup PB, Wetterslev J, Sivapalan P, Laake JH, Cronhjort M, Jakob SM, Cecconi M, Nalos M, Ostermann M, Malbrain M, Pettila V, Moller MH, Kjaer MN, Lange T, Overgaard-Steensen C, Brand BA, Winther-Olesen M, White JO, Quist L, Westergaard B, — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to resolution of hyperlactemia	Blood lactate < 2.0 mmol/L	72 hours
Secondary	Temporal changes in lactate concentrations over time	Difference in blood lactate at during the first 72h from enrollment	72 hours