HemodynamicsNCT01747057
Monitoring Resuscitation in Severe Sepsis and Septic Shock
A study testing Dynamic-parameters-guided fluid management and Standard-guided-fluid management in people with Hemodynamics, run by Corporacion Parc Tauli at 1 site in Spain.
Trial summary
Our hypothesis is that hemodynamic fluid resuscitation guided by dynamic parameters will improve outcome in patients with severe sepsis and septic shock, by limiting the deleterious effects of fluid overload. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemodynamics
- What is being tested?
- Dynamic-parameters-guided fluid management and Standard-guided-fluid management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 952 participants
- Where
- 1 siteSpain
- Study dates
- Mar 2013to May 2015
- 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 surgical direct view-).
- ≥ 2 SIRS criteria:
- Temperature < 36.0°C or > 38.0°C
- Heart rate > 90 bpm
- Respiratory rate > 20 rpm or PaCO2 < 32 mmHg or need of mechanical ventilation.
Show all 17Show fewer
- Leukocytes > 12.0 x109/L or < 4.0 x109/L
- Hemodynamic insufficiency defined as (at least one of the following):
- Sustained systemic hypotension (systolic arterial pressure ≤ 90 mmHg or MAP < 65 mmHg) or a decrease in MAP of > 30 mm Hg in a hypertensive patient.
- Need of vasopressors.
- Tachycardia (HR > 110 bpm) or bradycardia (HR < 55 bpm)
- Acute onset of oliguria, defined as a decreased urine output < 0.5 ml/kg/hr for ≥ 2 hours
- Serum lactate > 2 mmol/l
- Peripheral cyanosis, mottled skin, prolonged capillary refill
- Mechanical ventilation without any kind of inspiratory effort and Vt 7-10 mL/Kg, Pplateau < 30 mmH2O. Those patients with ARDS under mechanical ventilation will need to tolerate a tidal volume of at least 7 mL/Kg during 30 seconds while the plateau pressure remains < 30 mmH2O.
- Prior hemodynamic monitoring by arterial catheter.
- Central venous catheter.
Who cannot join
- Acute myocardial infarction < 7 days.
- Pregnancy
- Prior request of limited code status or expected life length lower than 3 months.
- Shock > 12h
- Cardiac arrhythmia
- Aortic valvular disease
- Inability to properly measure arterial pressure wave forms
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Area de Critics. Hospital de Sabadell
Sabadell, Barcelona, 08208
Gemma Goma, RN, 937231010 ext. 21179, ggoma@tauli.cat
Xaime Garcia, MD
About this study
Our hypothesis is that hemodynamic fluid resuscitation guided by dynamic parameters will improve outcome in patients with severe sepsis and septic shock, by limiting the deleterious effects of fluid overload.
Read the detailed description
To evaluate the efficacy of dynamic parameters versus static measures to guide fluid resuscitation we pretend to detect a 10% relative reduction in mortality. In addition, we pretend to observe an improvement on the length of resuscitation time, mechanical ventilation and vasopressor support-free days, ICU and hospital length of stay, organ failure and renal function.
- Conditions
- Hemodynamics
- Being tested
- Dynamic-parameters-guided fluid management, Standard-guided-fluid management
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dynamic-parameters-guided fluid managementBehavioural
● In preload-responsive patients defined by the following dynamic parameters: Patients fully adapted to mechanical ventilation* and with sinus rhythm.
- PPV >12%. PPV: Pulse pressure variation PPV = (PPmax-PPmin)/ [(PPmax+PPmin)/2] x100 (during 5 respiratory cycles)
- SVV > 12% (15). SVV: Stroke volume variation
- A tidal volume (Vt) ≥ 7-10cc/kg in mechanically ventilated (in a controlled mode - control volume or control pressure) and well-adapted patients without any inspiratory effort should be guaranteed.
Fluid loading must be performed with crystalloids (1omL/Kg) or colloids (5ml/Kg) every 30 minutes until PPV-SVV < 12%, while hypoperfusion signs are present. Continue resuscitation following Surviving Sepsis Campaign rules excluding more fluid administration (as described in the standard intervention once CVP>12).
● Non-preload responsive patients (defined as PPV or SVV < 12%) will resume the same protocol as responders when fluid response parameters are negative.
Standard-guided-fluid managementBehavioural
Fluid loading in patients with hypotension or elevated lactates until normalization of MAP (> 65mmHg) or CVP > 12mmHg. If CVP reaches > 12 mmHg and MAP remains < 65mmHg, norepinephrine should be started to reach MAP > 65mmHg. Once MAP is restored, if hypoperfusion signs persist (elevated lactate or urine output < 0.5mL/Kg/h), ScvO2/SvO2 must be measured. In order to reach a ScvO2 ≥70% or SVO2 ≥65%, consider giving blood transfusion if hemoglobin level (Hb) ≤ 7g/dL, and also consider dobutamine (initial dose 2,5 µg/kg/min, increased by 2,5 µg/kg/min every 30 min up to a maximum dose of 20 µg/kg/min, presence of arrhythmia, or FC>110bpm). At that point, if hypoperfusion signs remain present, consider restart protocol from the beginning.
| Study group | Role | What they receive |
|---|---|---|
| Dynamic guide resuscitation | Experimental | This arm follows a resuscitation protocol based on dynamic-parameters-guided fluid management. Receives: Behavioral: Dynamic-parameters-guided fluid management |
| Standard resuscitation | Active comparator | This arm follows a common resuscitation protocol based on Surviving Sepsis Campaign recommendations. Receives: Behavioral: Standard-guided-fluid management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality at 28 days
Measured: 28 days after hospital admission
Secondary outcomes (8)
Length of resuscitation
- Vasopressor use and fluid load between 0h to 6h
- Vasopressor use and fluid load between 7h to 72h
Measured: 72 hours after protocol inclusion
Ventilator-free days
From 1 to 28 days over 28 days in a month.
Measured: 28 days after admission
Vasopressor-free days
From 1 to 28 days over 28 days in a month.
Measured: 28 days after admission
Organ failure-free days
Cardiovascular, CNS, renal, hepatic, coagulation abnormalities. From 1 to 28 days over 28 days in a month.
Measured: 28 days after admission
ICU length of stay
Measured: At ICU discharge (expected average 30 days after admission)
Hospital length of stay
Measured: At hospital discharge (expected average 45 days after hospital admission)
Renal function evolution
Creatinin clearance will be calculated every day for the first 3 days (Cockroft-Gault formula).
Measured: 3 days after study enrollment
Mortality at 3 months
Measured: 3 months after admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2012 (estimated)
- Study startMar 2013
- Primary completionFeb 2015 (estimated)
- Study completionMay 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemodynamicsStudies 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
- 952 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Corporacion Parc Tauli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antonio Artigas Raventós, Corporacion Parc Tauli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01747057
- Sponsor's protocol ID
- MORESS
- Status last verified
- Feb 2014
- First submitted
- 29 Nov 2012
- Last updated
- 13 Feb 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring Resuscitation in Severe Sepsis and Septic Shock
- ClinicalTrials.gov ID
- NCT01747057
- Acronym / sponsor ID
- MORESS
- Conditions
- Hemodynamics
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 952 participants (estimated)
- Lead sponsor
- Corporacion Parc TauliUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Feb 2015 (estimated)
- Study completion
- May 2015 (estimated)
- First posted
- 11 Dec 2012 (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.
Our hypothesis is that hemodynamic fluid resuscitation guided by dynamic parameters will improve outcome in patients with severe sepsis and septic shock, by limiting the deleterious effects of fluid overload.
Detailed description
To evaluate the efficacy of dynamic parameters versus static measures to guide fluid resuscitation we pretend to detect a 10% relative reduction in mortality. In addition, we pretend to observe an improvement on the length of resuscitation time, mechanical ventilation and vasopressor support-free days, ICU and hospital length of stay, organ failure and renal function.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dynamic guide resuscitation | Experimental | Behavioral: Dynamic-parameters-guided fluid managementThis arm follows a resuscitation protocol based on dynamic-parameters-guided fluid management. |
| Standard resuscitation | Active comparator | Behavioral: Standard-guided-fluid managementThis arm follows a common resuscitation protocol based on Surviving Sepsis Campaign recommendations. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Age > 18 years
- Clinical evidence of sepsis (microbiology confirmation, radiological or direct view - pus in biological fluid or surgical direct view-).
- ≥ 2 SIRS criteria:
- Hemodynamic insufficiency defined as (at least one of the following):
- Mechanical ventilation without any kind of inspiratory effort and Vt 7-10 mL/Kg, Pplateau < 30 mmH2O. Those patients with ARDS under mechanical ventilation will need to tolerate a tidal volume of at least 7 mL/Kg during 30 seconds while the plateau pressure remains < 30 mmH2O.
Key exclusion criteria (7 listed)
- Acute myocardial infarction < 7 days.
- Pregnancy
- Prior request of limited code status or expected life length lower than 3 months.
- Shock > 12h
- Cardiac arrhythmia
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 |
|---|---|---|
| Dynamic-parameters-guided fluid management● In preload-responsive patients defined by the following dynamic parameters: Patients fully adapted to mechanical ventilation* and with sinus rhythm. 1. PPV >12%. PPV: Pulse pressure variation PPV = (PPmax-PPmin)/ [(PPmax+PPmin)/2] x100 (during 5 respiratory cycles) 2. SVV > 12% (15). SVV: Stroke volume variation * A tidal volume (Vt) ≥ 7-10cc/kg in mechanically ventilated (in a controlled mode - control volume or control pressure) and well-adapted patients without any inspiratory effort should be guaranteed. Fluid loading must be performed with crystalloids (1omL/Kg) or colloids (5ml/Kg) every 30 minutes until PPV-SVV < 12%, while hypoperfusion signs are present. Continue resuscitation following Surviving Sepsis Campaign rules excluding more fluid administration (as described in the standard intervention once CVP>12). ● Non-preload responsive patients (defined as PPV or SVV < 12%) will resume the same protocol as responders when fluid response parameters are negative. | Behavioural | Dynamic guide resuscitation |
| Standard-guided-fluid managementFluid loading in patients with hypotension or elevated lactates until normalization of MAP (> 65mmHg) or CVP > 12mmHg. If CVP reaches > 12 mmHg and MAP remains < 65mmHg, norepinephrine should be started to reach MAP > 65mmHg. Once MAP is restored, if hypoperfusion signs persist (elevated lactate or urine output < 0.5mL/Kg/h), ScvO2/SvO2 must be measured. In order to reach a ScvO2 ≥70% or SVO2 ≥65%, consider giving blood transfusion if hemoglobin level (Hb) ≤ 7g/dL, and also consider dobutamine (initial dose 2,5 µg/kg/min, increased by 2,5 µg/kg/min every 30 min up to a maximum dose of 20 µg/kg/min, presence of arrhythmia, or FC>110bpm). At that point, if hypoperfusion signs remain present, consider restart protocol from the beginning. | Behavioural | Standard resuscitation |
Primary outcome
Mortality at 28 days
Time frame: 28 days after hospital admission
8 secondary outcomes
Length of resuscitation
Time frame: 72 hours after protocol inclusion
Ventilator-free days
Time frame: 28 days after admission
Vasopressor-free days
Time frame: 28 days after admission
Organ failure-free days
Time frame: 28 days after admission
ICU length of stay
Time frame: At ICU discharge (expected average 30 days after admission)
Hospital length of stay
Time frame: At hospital discharge (expected average 45 days after hospital admission)
Renal function evolution
Time frame: 3 days after study enrollment
Mortality at 3 months
Time frame: 3 months after admission
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2014.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dynamic-parameters-guided fluid management and Standard-guided-fluid management in people with Hemodynamics, run by Corporacion Parc Tauli at 1 site in Spain.
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 17 inclusion and 7 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 13 Feb 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 Spain. 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 Xaime Garcia, MD (+34937231010 ext. 21156, xgarcia@tauli.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality at 28 days (time frame: 28 days after hospital admission). 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 13 Feb 2014.