Temporal Changes of Lactate in CLASSIC Patients

NCT05629780 | Completed

• 1 other identifier: Dnr 2021-06283-02
• Study Type: interventional
• Target: 777
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Septic Shock

Outcome Measures

Primary Outcomes (1)

• Time to resolution of hyperlactemia

  Blood lactate \< 2.0 mmol/L

  72 hours

Secondary Outcomes (1)

• Temporal changes in lactate concentrations over time

  72 hours

Study Arms (2)

Conservative

EXPERIMENTAL

Resuscitation fluids were only given under certain pre-defined criteria

Drug: Resuscitation fluid

Traditional (liberal)

NO INTERVENTION

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

Interventions

Resuscitation fluid DRUG

Cristalloid fluids given as a resuscitational intervention

Conservative

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participation in CLASSIC trial in any of the participating centres

You may not qualify if:

• Lack of sufficient data for analysis

Sponsors & Collaborators

• Karolinska University Hospital: lead
• Collabortation for Research in Intensive Care (CRIC): collaborator
• European Society of Intensive Care Medicine: collaborator
• Region Stockholm: collaborator
• The Scandinavian Society of Anaesthesiology and Intensive Care Medicine (SSAI): collaborator

Study Sites (1)

Karolinska University Hospital

Stockholm, 14186, Sweden

Location

Related 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, Jonsson AB, Hjortso CJS, Meier N, Jensen TS, Engstrom J, Nebrich L, Andersen-Ranberg NC, Jensen JV, Joseph NA, Poulsen LM, Herlov LS, Solling CG, Pedersen SK, Knudsen KK, Straarup TS, Vang ML, Bundgaard H, Rasmussen BS, Aagaard SR, Hildebrandt T, Russell L, Bestle MH, Schonemann-Lund M, Brochner AC, Elvander CF, Hoffmann SKL, Rasmussen ML, Martin YK, Friberg FF, Seter H, Aslam TN, Adnoy S, Seidel P, Strand K, Johnstad B, Joelsson-Alm E, Christensen J, Ahlstedt C, Pfortmueller CA, Siegemund M, Greco M, Radej J, Kriz M, Gould DW, Rowan KM, Mouncey PR, Perner A; CLASSIC Trial Group. Restriction of Intravenous Fluid in ICU Patients with Septic Shock. N Engl J Med. 2022 Jun 30;386(26):2459-2470. doi: 10.1056/NEJMoa2202707. Epub 2022 Jun 17.

  PMID: 35709019 RESULT

MeSH Terms

Conditions

Shock, Septic

Condition Hierarchy (Ancestors)

Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: 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.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, PhD

Model Details: This is a retrospective analysis of patients recruited to an interventional multicenter trial.

Study Record Dates

• First Submitted: November 14, 2022
• First Posted: November 29, 2022
• Study Start: September 29, 2022
• Primary Completion: December 28, 2022
• Study Completion: June 14, 2023
• Last Updated: September 14, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)