Septic ShockReSSeSNCT02150512
Resuscitation Strategies in Septic Shock
A study testing Transpulmonary Thermodilution and Surviving Sepsis Guidelines (SSG) in people with Septic Shock and Critically Ill, run by Medisch Spectrum Twente at 1 site in Netherlands.
Trial summary
The purpose of this study, in mechanically ventilated septic shock patients, is to determine whether a fluid loading strategy based on parameters derived from the transpulmonary thermodilution technique may lead to more ventilator free days compared to a fluid loading strategy based on the surviving sepsis guidelines. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Septic Shock, Critically Ill
- What is being tested?
- Transpulmonary Thermodilution and Surviving Sepsis Guidelines (SSG)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 1 siteNetherlands
- Study dates
- Nov 2014to Dec 2016
- 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
- Age > 18 years
- Clinical evidence of sepsis (microbiology confirmation, radiological or direct view (pus in biological fluid) or direct surgical view).
- ≥ 2 SIRS criteria:
- Temperature < 36.0°C or > 38.0°C
- Heart rate > 90 bpm
- Respiratory rate > 20 rpm or PaCO2 < 4.2 kPa or need of mechanical ventilation.
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- Leukocytes > 12.0 x109/L or < 4.0 x109/L or >10% bands
- Circulatory shock defined as sustained systemic hypotension (systolic arterial pressure <90 mmHg or MAP <65 mmHg (<75 mmHg in a hypertensive patient) despite a 1,000 ml IV fluid challenge over 30 min (including IV fluids administered pre-ICU) or the need for vasopressor therapy. Hypertensive patients are patients with a history of confirmed hypertension treated with antihypertensive agents.
- Mechanical ventilation by endotracheal tube (any form)
Who cannot join
- Pregnancy
- Pre-terminal illness with life expectancy <28 days
- Duration of circulatory shock >6 hours
- Severe peripheral arterial vascular occlusion disease (Fontaine level III-IV)
- Inability for femoral artery canulation
- No informed consent
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Medisch Spectrum Twente
Enschede
RJ Trof, MD PhD, r.trof@mst.nl
Research IC, researchIC@mst.nl
About this study
Official title: Resuscitation Strategies in Septic Shock. A Randomized Controlled Trial of Two Different Fluid Loading Strategies in ICU Patients With Early Septic Shock
The purpose of this study, in mechanically ventilated septic shock patients, is to determine whether a fluid loading strategy based on parameters derived from the transpulmonary thermodilution technique may lead to more ventilator free days compared to a fluid loading strategy based on the surviving sepsis guidelines.
Read the detailed description
Rationale: Fluid loading is an important intervention in patients with severe sepsis and septic shock in order to prevent development of multi organ failure and mortality. The Surviving Sepsis Guidelines recommend during the first 6 hours of resuscitation a central venous pressure (CVP) based fluid loading approach, targeting to 12-15 mmHg in mechanically ventilated patients. CVP however has proven to be a poor indicator for preload and preload dependency, while dynamic parameters as stroke volume variation (SVV) derived from the transpulmonary thermodilution technique (TPTD) are superior. Together with the ability to measure the extravascular lung water (EVLW), the TPTD technique may guide fluid management more accurately and may prevent deleterious fluid overloading.
Objective: The risk of fluid overloading in mechanically ventilated patients with septic shock is less when fluid administration is based on a fluid loading protocol using SVV together with EVLW measurements than applying the Surviving Sepsis Guidelines targeting CVP to 12-15 mmHg, in at least the first 6 hours of resuscitation, translating in more ventilator free days (VFDs) Study design: This is a prospective, randomized, non-blinded, single-center, controlled clinical trial comparing two different fluid resuscitation strategies in patients with septic shock. Patients will be randomized for fluid management based on the Surviving Sepsis Guidelines (SSG) or based transpulmonary thermodilution (TPTD) derived SVV and EVLW in at least the first 6 hours of resuscitation.
Study population: All patients of ≥18 years admitted to the ICU because of septic shock together with the need for mechanical ventilation are eligible for randomization Intervention: During at least the first 6 hours of resuscitation, the standard group (SSG guided therapy) follows a fluid resuscitation protocol based on the Surviving Sepsis Campaign recommendations. Initial trigger for fluid loading when circulatory insufficiency is present will be the CVP (target ≥12 mmHg). The intervention group (TPTD guided therapy) follows a fluid resuscitation protocol based on SVV and EVLW. Initial trigger for fluid loading when circulatory insufficiency is present will be SVV. The study protocol will be applied up to a maximum of 72 hours.
Main study parameters/endpoints: VFDs on day 28. Benefit and risks associated with participation: Since inclusion criteria include a TPTD (5F fiber optic, femoral artery) catheter, the inconvenience as compared to standard treatment is minimal. Current routine hospital policy involves TPTD catheter insertion in most of the patients meeting the inclusion criteria specified above.
- Conditions
- Septic Shock, Critically Ill
- Being tested
- Transpulmonary Thermodilution, Surviving Sepsis Guidelines (SSG)
- Keywords
- Septic shock, Critically ill patients, Transpulmonary thermodilution, Fluid resuscitation
- Medical subject headings
- Shock, Septic, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transpulmonary ThermodilutionDevice
Also called PiCCO, Pulsion Medical Systems, Germany
Initial trigger for fluid loading when circulatory insufficiency is present will be SVV. If SVV ≤10% in patients on controlled mechanical ventilation with tidal volumes of ≥8 ml/kg, fluid loading will not be performed. If SVV >10% or spontaneous breathing efforts are present, a fluid challenge should be performed. Also if patients are on controlled mechanical ventilation with tidal volumes of ≤7 ml/kg, a fluid challenge should be performed. If fluid responsiveness is present and SVV decreases to ≤10%, further fluid loading should be stopped. If SVV is still >10%, the increase in EVLW will decide whether to continue fluid loading or not; if EVLW is ≥12 mL/kg PBW and EVLW increases upon fluid loading, further fluid loading should be stopped.
Surviving Sepsis Guidelines (SSG)Device
Initial trigger for fluid loading when circulatory insufficiency is present will be the CVP (target ≥12 mmHg). If circulatory insufficiency is absent, fluid loading will not be initiated or stopped independently of the actual CVP level.
| Study group | Role | What they receive |
|---|---|---|
| Transpulmonary thermodilution (TPTD) | Experimental | The intervention group (TPTD guided therapy) follows a fluid resuscitation protocol based on stroke volume variation (SVV) and extravascular lung water (EVLW). Initial trigger for fluid loading when circulatory insufficiency is present will be SVV. Receives: Device: Transpulmonary Thermodilution |
| Surviving Sepsis Guidelines (SSG) | Active comparator | The standard group (SSG guided therapy) follows a fluid resuscitation protocol based on the Surviving Sepsis Campaign recommendations. Initial trigger for fluid loading when circulatory insufficiency is present will be the CVP (target ≥12 mmHg). Receives: Device: Surviving Sepsis Guidelines (SSG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
ventilator free days (VFDs)
VFDs from enrolment to extubation until day 28
Measured: 28 days
Secondary outcomes (1)
duration of circulatory shock (hours)
Duration of circulatory shock, defined as the amount of consecutive hours on vasopressor therapy
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 posted30 May 2014 (estimated)
- Study startNov 2014
- Primary completionOct 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Septic ShockStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medisch Spectrum Twente
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, RJ Trof, Medisch Spectrum Twente
- Investigators
- RJ Trof, MD PhD, Principal investigator, Medisch Spectrum Twente, department of Intensive CareA Beishuizen, MD PhD, Study director, Medisch Spectrum Twente, department of Intensive Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02150512
- Sponsor's protocol ID
- ReSSeS-2014
- Acronym
- ReSSeS
- Status last verified
- Nov 2014
- First submitted
- 19 May 2014
- Last updated
- 21 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Resuscitation Strategies in Septic Shock. A Randomized Controlled Trial of Two Different Fluid Loading Strategies in ICU Patients With Early Septic Shock
- ClinicalTrials.gov ID
- NCT02150512
- Acronym / sponsor ID
- ReSSeS / ReSSeS-2014
- Conditions
- Septic Shock, Critically Ill
- Keywords
- Septic shock, Critically ill patients, Transpulmonary thermodilution, Fluid resuscitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Medisch Spectrum TwenteUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Oct 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 30 May 2014 (estimated)
- 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 purpose of this study, in mechanically ventilated septic shock patients, is to determine whether a fluid loading strategy based on parameters derived from the transpulmonary thermodilution technique may lead to more ventilator free days compared to a fluid loading strategy based on the surviving sepsis guidelines.
Detailed description
Rationale: Fluid loading is an important intervention in patients with severe sepsis and septic shock in order to prevent development of multi organ failure and mortality. The Surviving Sepsis Guidelines recommend during the first 6 hours of resuscitation a central venous pressure (CVP) based fluid loading approach, targeting to 12-15 mmHg in mechanically ventilated patients. CVP however has proven to be a poor indicator for preload and preload dependency, while dynamic parameters as stroke volume variation (SVV) derived from the transpulmonary thermodilution technique (TPTD) are superior. Together with the ability to measure the extravascular lung water (EVLW), the TPTD technique may guide fluid management more accurately and may prevent deleterious fluid overloading.
Objective: The risk of fluid overloading in mechanically ventilated patients with septic shock is less when fluid administration is based on a fluid loading protocol using SVV together with EVLW measurements than applying the Surviving Sepsis Guidelines targeting CVP to 12-15 mmHg, in at least the first 6 hours of resuscitation, translating in more ventilator free days (VFDs) Study design: This is a prospective, randomized, non-blinded, single-center, controlled clinical trial comparing two different fluid resuscitation strategies in patients with septic shock. Patients will be randomized for fluid management based on the Surviving Sepsis Guidelines (SSG) or based transpulmonary thermodilution (TPTD) derived SVV and EVLW in at least the first 6 hours of resuscitation.
Study population: All patients of ≥18 years admitted to the ICU because of septic shock together with the need for mechanical ventilation are eligible for randomization Intervention: During at least the first 6 hours of resuscitation, the standard group (SSG guided therapy) follows a fluid resuscitation protocol based on the Surviving Sepsis Campaign recommendations. Initial trigger for fluid loading when circulatory insufficiency is present will be the CVP (target ≥12 mmHg). The intervention group (TPTD guided therapy) follows a fluid resuscitation protocol based on SVV and EVLW. Initial trigger for fluid loading when circulatory insufficiency is present will be SVV. The study protocol will be applied up to a maximum of 72 hours.
Main study parameters/endpoints: VFDs on day 28. Benefit and risks associated with participation: Since inclusion criteria include a TPTD (5F fiber optic, femoral artery) catheter, the inconvenience as compared to standard treatment is minimal. Current routine hospital policy involves TPTD catheter insertion in most of the patients meeting the inclusion criteria specified above.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transpulmonary thermodilution (TPTD) | Experimental | Device: Transpulmonary ThermodilutionThe intervention group (TPTD guided therapy) follows a fluid resuscitation protocol based on stroke volume variation (SVV) and extravascular lung water (EVLW). Initial trigger for fluid loading when circulatory insufficiency is present will be SVV. |
| Surviving Sepsis Guidelines (SSG) | Active comparator | Device: Surviving Sepsis Guidelines (SSG)The standard group (SSG guided therapy) follows a fluid resuscitation protocol based on the Surviving Sepsis Campaign recommendations. Initial trigger for fluid loading when circulatory insufficiency is present will be the CVP (target ≥12 mmHg). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age > 18 years
- Clinical evidence of sepsis (microbiology confirmation, radiological or direct view (pus in biological fluid) or direct surgical view).
- ≥ 2 SIRS criteria:
- Circulatory shock defined as sustained systemic hypotension (systolic arterial pressure <90 mmHg or MAP <65 mmHg (<75 mmHg in a hypertensive patient) despite a 1,000 ml IV fluid challenge over 30 min (including IV fluids administered pre-ICU) or the need for vasopressor therapy. Hypertensive patients are patients with a history of confirmed hypertension treated with antihypertensive agents.
- Mechanical ventilation by endotracheal tube (any form)
Key exclusion criteria (6 listed)
- Pregnancy
- Pre-terminal illness with life expectancy <28 days
- Duration of circulatory shock >6 hours
- Severe peripheral arterial vascular occlusion disease (Fontaine level III-IV)
- Inability for femoral artery canulation
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 |
|---|---|---|
| Transpulmonary ThermodilutionAlso: PiCCO, Pulsion Medical Systems, GermanyInitial trigger for fluid loading when circulatory insufficiency is present will be SVV. If SVV ≤10% in patients on controlled mechanical ventilation with tidal volumes of ≥8 ml/kg, fluid loading will not be performed. If SVV >10% or spontaneous breathing efforts are present, a fluid challenge should be performed. Also if patients are on controlled mechanical ventilation with tidal volumes of ≤7 ml/kg, a fluid challenge should be performed. If fluid responsiveness is present and SVV decreases to ≤10%, further fluid loading should be stopped. If SVV is still >10%, the increase in EVLW will decide whether to continue fluid loading or not; if EVLW is ≥12 mL/kg PBW and EVLW increases upon fluid loading, further fluid loading should be stopped. | Device | Transpulmonary thermodilution (TPTD) |
| Surviving Sepsis Guidelines (SSG)Initial trigger for fluid loading when circulatory insufficiency is present will be the CVP (target ≥12 mmHg). If circulatory insufficiency is absent, fluid loading will not be initiated or stopped independently of the actual CVP level. | Device | Surviving Sepsis Guidelines (SSG) |
Primary outcome
ventilator free days (VFDs)
Time frame: 28 days
VFDs from enrolment to extubation until day 28
1 secondary outcome
duration of circulatory shock (hours)
Time frame: 72 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2014.
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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.
RJ Trof, MD PhD principal investigator
Medisch Spectrum Twente, department of Intensive Care
A Beishuizen, MD PhD study director
Medisch Spectrum Twente, department of Intensive Care
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transpulmonary Thermodilution and Surviving Sepsis Guidelines (SSG) in people with Septic Shock and Critically Ill, run by Medisch Spectrum Twente at 1 site in Netherlands.
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 9 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 21 Nov 2014. 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 Netherlands. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact RJ Trof, MD PhD (0031-53-4872000, r.trof@mst.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ventilator free days (VFDs) (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Nov 2014.