Shock, SepticNCT05249088
Protocolized Reduction of Non-resuscitation Fluids vs Usual Care in Septic Shock Feasibility Trial
A study testing Protocolised reduction of non-resuscitation fluids in people with Shock, Septic, run by Region Skane at 8 sites in Sweden.
Trial summary
The objectives of this feasibility trial are to assess the efficacy and feasibility of methods and procedures of a protocol purposed to compare a reduction of administration of non-resuscitation fluids to usual care in patients with septic shock. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Shock, Septic
- What is being tested?
- Protocolised reduction of non-resuscitation fluids
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 8 sitesSweden
- Study dates
- 1 Mar 2022to 27 Mar 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
- Adult (≥ 18 years of age)
- Septic shock according to the Sepsis 3 criteria: suspected or confirmed infection AND infusion of vasopressor/inotrope to maintain mean arterial pressure of 65 mmHg or above despite adequate fluid resuscitation AND lactate of 2 mmol/L or above at any time following ICU admission when there was a simultaneous need for vasopressor/inotrope.
Who cannot join
- Confirmed or suspected pregnancy
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Sweden8 sites
Sahlgrenska University Hospital
Gothenburg
Halmstad Hospital
Halmstad
Helsingborg Hospital
Helsingborg
Kristianstad Hospital
Kristianstad
Skåne University Hospital, Lund
Lund
Skåne University Hospital, Malmö
Malmö
Östersund Hospital
Östersund
Uppsala University Hospital
Uppsala
About this study
Official title: Protocolized Reduction of Non-resuscitation Fluids Versus Usual Care in Septic Shock Patients: A Multicentre Feasibility Trial
The objectives of this feasibility trial are to assess the efficacy and feasibility of methods and procedures of a protocol purposed to compare a reduction of administration of non-resuscitation fluids to usual care in patients with septic shock.
- Conditions
- Shock, Septic
- Being tested
- Protocolised reduction of non-resuscitation fluids, Usual care
- Medical subject headings
- Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Protocolised reduction of non-resuscitation fluidsOther
- Maintenance fluids are discontinued in participants with positive cumulative fluid balance who are not dehydrated
- Intravenous fluid and enteral water are given as needed to correct electrolyte disturbances
- Enteral nutrition with energy density of at least 2 kcal/ml is administered according to local practice
- Starting 72 hours after inclusion, glucose at a concentration of at least 20% and a maximal dose of 1g/kg/day may be used as nutrition if enteral feeding is not tolerated. Glucose at this dose or lower may be started earlier in patients with insulin dependent diabetes if enteral feeding is not tolerated and local protocol mandates this
- Parenteral nutrition is administered according to local protocol
- Intravenous medications are concentrated according to a predefined protocol
- Patients with neutral or negative cumulative fluid balance receive maintenance and other fluids such that total dose of fluids covers the daily need of water (about 1ml/kg/h)
Usual careOther
Participants receive non-resuscitation fluids according to local routines, with the following stipulations:
- Maintenance fluids (crystalloids and/or glucose and/or enteral water) are given at a dose of 1 ml/kg/h unless local protocol states otherwise
- Glucose is used at maximal concentration of 10% unless local protocol states otherwise.
- Medications are concentrated according to local protocol
| Study group | Role | What they receive |
|---|---|---|
| Protocolised reduction of non-resuscitation fluids | Experimental | Participants receive non-resuscitation fluids according to a pre-defined protocol starting within two hours of randomization. The intervention is continued for the duration of the ICU admission up to a maximum of 90 days. Receives: Other: Protocolised reduction of non-resuscitation fluids |
| Usual Care | Other | Participants receive non-resuscitation fluids according to local routines. Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in fluid administration
Total difference in litres of administered fluids between groups
Measured: Within the first three days after inclusion (days 0-3)
Secondary outcomes (4)
Proportion of participants with sufficient clinical outcome data
Fraction of randomised patients with sufficient data for the following clinical outcomes: all-cause mortality, days alive and free of mechanical ventilation, acute kidney injury, and ischemic events in the ICU (cerebral, cardiac, intestinal or limb ischemia)
Measured: Within 90 days after inclusion
Proportion of participants assessed by EQ5D-5L and MoCA
Fraction of surviving randomized patients who were assessed by European Quality of Life-5 Dimensions 5- Level questionnaire (EQ5D-5L) and The Montreal Cognitive Assessment (MoCA)
Measured: 6 months after inclusion
Inclusion of eligible patients
Fraction of all eligible patients who were randomised and consented
Measured: During inclusion
Protocol violations
Fraction of patients experiencing at least one protocol violation
Measured: Within 90 days after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2022
- Study start1 Mar 2022
- Primary completion13 Sep 2022
- Study completion27 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Shock, SepticStudies of the same condition, open and under way.
- More trials run by Region SkaneThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter Bentzer, MD, PhD, Principal investigator, Region Skane
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05249088
- Sponsor's protocol ID
- REDUSE feasibility trial
- Status last verified
- Oct 2023
- First submitted
- 8 Feb 2022
- Last updated
- 11 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Beginning 9 months after publication of the main report of this trial individual de-identified data will be available for sharing with researchers who provide a methodologically sound proposal as judged by the steering committee. To gain access, data requestors will need to sign a data access agreement.
Publications
Linden A, Fisher J, Lilja G, Olsen MH, Sjovall F, Jungner M, Spangfors M, Samuelsson L, Oras J, Linder A, Unden J, Kander T, Lipcsey M, Nielsen N, Jakobsen JC, Bentzer P. Protocolised reduction of non-resuscitation fluids versus usual care in patients with septic shock (REDUSE): a protocol for a multicentre feasibility trial. BMJ Open. 2023 Feb 28;13(2):e065392. doi: 10.1136/bmjopen-2022-065392.
PubMed 36854601Linden A, Spangfors M, Olsen MH, Fisher J, Lilja G, Sjovall F, Jungner M, Lengquist M, Kander T, Samuelsson L, Johansson J, Palmnas E, Unden J, Oras J, Cronhjort M, Chew M, Linder A, Lipcsey M, Nielsen N, Jakobsen JC, Bentzer P; REDUSE Trial Group. Protocolized reduction of non-resuscitation fluids versus usual care in septic shock patients (REDUSE): a randomized multicentre feasibility trial. Crit Care. 2024 May 17;28(1):166. doi: 10.1186/s13054-024-04952-w.
PubMed 38760833
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protocolized Reduction of Non-resuscitation Fluids Versus Usual Care in Septic Shock Patients: A Multicentre Feasibility Trial
- ClinicalTrials.gov ID
- NCT05249088
- Acronym / sponsor ID
- REDUSE feasibility trial
- Conditions
- Shock, Septic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 13 Sep 2022 (actual)
- Study completion
- 27 Mar 2023 (actual)
- First posted
- 21 Feb 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.
The objectives of this feasibility trial are to assess the efficacy and feasibility of methods and procedures of a protocol purposed to compare a reduction of administration of non-resuscitation fluids to usual care in patients with septic shock.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Protocolised reduction of non-resuscitation fluids | Experimental | Other: Protocolised reduction of non-resuscitation fluidsParticipants receive non-resuscitation fluids according to a pre-defined protocol starting within two hours of randomization. The intervention is continued for the duration of the ICU admission up to a maximum of 90 days. |
| Usual Care | Other | Other: Usual careParticipants receive non-resuscitation fluids according to local routines. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult (≥ 18 years of age)
- Septic shock according to the Sepsis 3 criteria: suspected or confirmed infection AND infusion of vasopressor/inotrope to maintain mean arterial pressure of 65 mmHg or above despite adequate fluid resuscitation AND lactate of 2 mmol/L or above at any time following ICU admission when there was a simultaneous need for vasopressor/inotrope.
Key exclusion criteria (1 listed)
- Confirmed or suspected pregnancy
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 |
|---|---|---|
| Protocolised reduction of non-resuscitation fluids* Maintenance fluids are discontinued in participants with positive cumulative fluid balance who are not dehydrated * Intravenous fluid and enteral water are given as needed to correct electrolyte disturbances * Enteral nutrition with energy density of at least 2 kcal/ml is administered according to local practice * Starting 72 hours after inclusion, glucose at a concentration of at least 20% and a maximal dose of 1g/kg/day may be used as nutrition if enteral feeding is not tolerated. Glucose at this dose or lower may be started earlier in patients with insulin dependent diabetes if enteral feeding is not tolerated and local protocol mandates this * Parenteral nutrition is administered according to local protocol * Intravenous medications are concentrated according to a predefined protocol * Patients with neutral or negative cumulative fluid balance receive maintenance and other fluids such that total dose of fluids covers the daily need of water (about 1ml/kg/h) | Other | Protocolised reduction of non-resuscitation fluids |
| Usual careParticipants receive non-resuscitation fluids according to local routines, with the following stipulations: * Maintenance fluids (crystalloids and/or glucose and/or enteral water) are given at a dose of 1 ml/kg/h unless local protocol states otherwise * Glucose is used at maximal concentration of 10% unless local protocol states otherwise. * Medications are concentrated according to local protocol | Other | Usual Care |
Primary outcome
Difference in fluid administration
Time frame: Within the first three days after inclusion (days 0-3)
Total difference in litres of administered fluids between groups
4 secondary outcomes
Proportion of participants with sufficient clinical outcome data
Time frame: Within 90 days after inclusion
Proportion of participants assessed by EQ5D-5L and MoCA
Time frame: 6 months after inclusion
Inclusion of eligible patients
Time frame: During inclusion
Protocol violations
Time frame: Within 90 days after inclusion
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 11 Dec 2023.
- Background: PubMed 36854601Linden A, Fisher J, Lilja G, Olsen MH, Sjovall F, Jungner M, Spangfors M, Samuelsson L, Oras J, Linder A, Unden J, Kander T, Lipcsey M, Nielsen N, Jakobsen JC, Bentzer P. Protocolised reduction of non-resuscitation fluids versus usual care in patients with septic shock (REDUSE): a protocol for a multicentre feasibility trial. BMJ Open. 2023 Feb 28;13(2):e065392. doi: 10.1136/bmjopen-2022-065392.
- Derived from this study: PubMed 38760833Linden A, Spangfors M, Olsen MH, Fisher J, Lilja G, Sjovall F, Jungner M, Lengquist M, Kander T, Samuelsson L, Johansson J, Palmnas E, Unden J, Oras J, Cronhjort M, Chew M, Linder A, Lipcsey M, Nielsen N, Jakobsen JC, Bentzer P; REDUSE Trial Group. Protocolized reduction of non-resuscitation fluids versus usual care in septic shock patients (REDUSE): a randomized multicentre feasibility trial. Crit Care. 2024 May 17;28(1):166. doi: 10.1186/s13054-024-04952-w.
- Markus Harboe Olsen, et al. Protocolised Reduction of Non-resuscitation Fluids Versus Usual Care in Septic Shock Patients (REDUSE) - a Statistical Analysis Plan for a Multicentre Feasibility Trial. 3.00, Zenodo, Dec. 2022, doi:10.5281/zenodo.7392132.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Beginning 9 months after publication of the main report of this trial individual de-identified data will be available for sharing with researchers who provide a methodologically sound proposal as judged by the steering committee. To gain access, data requestors will need to sign a data access agreement.
Related trials for Shock, Septic
Active, not recruitingPhase 4
Thymosin Alpha 1 and IgM Levels in Sepsis
Sepsis, Septic Shock
Not yet recruiting
Vitamin C for Acute Kidney Injury in ACLF With Septic Shock: A Randomized Controlled Trial
Acute-on-Chronic Liver Failure (ACLF)
Not yet recruiting
ICU-SUCCEED for Survivors of Acute Respiratory Failure and Their Caregivers
Acute Respiratory Failure, Critical Illness
Not yet recruitingObservational study
Longitudinal Trajectories of Myocardial Work in Patients With Sepsis
Sepsis, Septic Shock Hyperdynamic
RecruitingObservational study
Immunothrombosis With Septic Shock Undergoing Renal Replacement Therapy With the OXIRIS Membrane
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.
Peter Bentzer, MD, PhD principal investigator
Region Skane
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Protocolised reduction of non-resuscitation fluids in people with Shock, Septic, run by Region Skane at 8 sites 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 2 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 11 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites 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?
Difference in fluid administration (time frame: Within the first three days after inclusion (days 0-3)). 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 NCT05249088, which also lists 2 linked publications.
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 11 Dec 2023.