Septic ShockNCT05629780
Temporal Changes of Lactate in CLASSIC Patients
A study testing Resuscitation fluid in people with Septic Shock, run by Karolinska University Hospital at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Septic Shock
- What is being tested?
- Resuscitation fluid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 777 participants
- Where
- 1 siteSweden
- Study dates
- 29 Sep 2022to 14 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participation in CLASSIC trial in any of the participating centres
Who cannot join
- Lack of sufficient data for analysis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Temporal Changes in Plasma Lactate Concentration in Critically Ill Patients With Septic Shock Treated With Restrictive Compared to Standard Fluid Therapy
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.
Read the 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
- Being tested
- Resuscitation fluid
- Medical subject headings
- Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resuscitation fluidDrug
Cristalloid fluids given as a resuscitational intervention
| Study group | Role | What they receive |
|---|---|---|
| Conservative | Experimental | Resuscitation fluids were only given under certain pre-defined criteria Receives: Drug: Resuscitation fluid |
| Traditional (liberal) | No intervention | Patients were treated with standard of care for each site with regards to recuscitation fluids. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to resolution of hyperlactemia
Blood lactate < 2.0 mmol/L
Measured: 72 hours
Secondary outcomes (1)
Temporal changes in lactate concentrations over time
Difference in blood lactate at during the first 72h from enrollment
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2022
- Study start29 Sep 2022
- Primary completion28 Dec 2022
- Study completion14 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Septic ShockStudies of the same condition, open and under way.
- More trials run by Karolinska University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a retrospective analysis of patients recruited to an interventional multicenter trial.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 777 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- 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)
- Responsible party
- Principal investigator, Jonathan Grip, Karolinska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05629780
- Sponsor's protocol ID
- Dnr 2021-06283-02
- Status last verified
- Sep 2023
- First submitted
- 14 Nov 2022
- Last updated
- 14 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35709019
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Temporal Changes in Plasma Lactate Concentration in Critically Ill Patients With Septic Shock Treated With Restrictive Compared to Standard Fluid Therapy
- ClinicalTrials.gov ID
- NCT05629780
- Acronym / sponsor ID
- Dnr 2021-06283-02
- Conditions
- Septic Shock
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 777 participants (actual)
- Lead sponsor
- Karolinska University HospitalUniversity, hospital or other
- Collaborators
- 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)
- Study start
- 29 Sep 2022 (actual)
- Primary completion
- 28 Dec 2022 (actual)
- Study completion
- 14 Jun 2023 (actual)
- First posted
- 29 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- This is a retrospective analysis of patients recruited to an interventional multicenter trial.
| Arm | Type | Receives |
|---|---|---|
| Conservative | Experimental | Drug: Resuscitation fluidResuscitation fluids were only given under certain pre-defined criteria |
| Traditional (liberal) | No intervention | –Patients were treated with standard of care for each site with regards to recuscitation fluids. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Participation in CLASSIC trial in any of the participating centres
Key exclusion criteria (1 listed)
- Lack of sufficient data for analysis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Resuscitation fluidCristalloid fluids given as a resuscitational intervention | Drug | Conservative |
Primary outcome
Time to resolution of hyperlactemia
Time frame: 72 hours
Blood lactate < 2.0 mmol/L
1 secondary outcome
Temporal changes in lactate concentrations over time
Time frame: 72 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2023.
- Results publication: PubMed 35709019Meyhoff 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.
- Individual participant dataSharing planned: No
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Sepsis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resuscitation fluid in people with Septic Shock, run by Karolinska University Hospital at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to resolution of hyperlactemia (time frame: 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05629780, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2023.