Trials Sponsors Conditions Drugs Pricing

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 fluidDrug

Cristalloid fluids given as a resuscitational intervention

Conservative

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Participation in CLASSIC trial in any of the participating centres

You may not qualify if:

Sponsors & Collaborators

Collabortation for Research in Intensive Care (CRIC)
Type not reportedcollaborator
The Scandinavian Society of Anaesthesiology and Intensive Care Medicine (SSAI)
Type not reportedcollaborator

Study Sites (1)

Karolinska University Hospital

Stockholm, 14186, Sweden

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: 35709019RESULT

MeSH Terms

Conditions

Shock, Septic

Condition Hierarchy (Ancestors)

SepsisInfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShock

Enrollment

777 participants (actual enrollment reported by the registry).

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

Study Record Dates

First Submitted

November 14, 2022

First Posted

November 29, 2022

Temporal Changes of Lactate in CLASSIC Patients

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

Conservative

Traditional (liberal)

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

Data Sharing

Source record

Documents

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

Conservative

Traditional (liberal)

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

Data Sharing

Source record

Documents

Locations