Severe SepsisPhase 4VOMOSEPNCT02587078
Volume Therapy With Crystalloids and Colloids and Hemodynamic Monitoring in Patients With Severe Sepsis
A Phase 4 study testing Volulyte and Jonosteril in people with Severe Sepsis, run by Wuerzburg University Hospital.
Trial summary
The primary alternative hypothesis is that less time (minutes) is required, to achieve the initial hemodynamic stabilization, with Volulyte® compared to Jonosteril®. H01: Minutes with Volulyte® ≥ Minutes with Jonosteril® H11: Minutes with Volulyte® < Minutes with Jonosteril® Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Severe Sepsis
- What is being tested?
- Volulyte and Jonosteril
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Mar 2013to Jun 2013
- Phase
- Phase 4
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Prior written informed consent of the patient. If this is not possible, it will be necessary for the investigator to obtain initial informed consent according to the requirements. The legally authorized representative has to provide the written informed consent or in his absence a declaration for inclusion in an emergency situation is to be signed by a consultant physician who is not involved in the study and who is independent of the investigational team. If the patient dies following the inclusion in the clinical trial based on the consulting physician´s vote and no legally authorized representative is available / able to give informed consent, no additional informed consent will be needed and the consultant physician´s vote will be considered sufficient.
- Male or female patient aged 18 years or older
- Presence of severe sepsis defined as:
- Sepsis due to a known or suspected infection with two or more of the modified systemic inflammatory response syndrome (SIRS) criteria (46).
- Temperature (> 38°C or < 36°C)
- Heart rate (> 90 beats / minute)
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- Respiratory rate (>20 breaths / minute) or arterial carbon dioxide (PaCO2) < 32 mmHg (< 4.3 kPa)
- White blood cells (WBC) > 12.000 cells/mm3, < 4000 cells/mm3, or > 10% immature (band) forms
- Severe sepsis for less than 24 hours with at least one of the following characteristics:
- Ratio of partial pressure of oxygen to the fraction of inspired oxygen (PaO2/FiO2) < 250
- Arterial pH < 7.3 or serum lactate level > 1.5 × ULN (upper limit of normal)
- Hypotension: Inadequately fluid resuscitated patients with a systolic blood pressure ≤ 90 mmHg or MAP ≤ 70 mmHg, or adequately fluid resuscitated patients requiring vasopressors to maintain blood pressure within normal ranges
- Urine output < 0.5 ml/kg/hour (patients who are inadequately fluid resuscitated)
- Platelet count < 80.000/ mm3
- Acute alteration of mental status
- Requirement for fluid resuscitation as defined by the measured hemodynamic parameters MAP, ScvO2 and PPV or PLR.
Who cannot join
- Volume expansion with a dosage of HES administered prior to randomization rendering a patient unsuitable for inclusion based on the treating physician´s discretion in consideration of the suggested maximal dose/day.
- Known volume expansion with any dosage of HES 200.000 prior to inclusion during the actual hospital admission.
- Participation in another clinical study with an investigational drug or an investigational medical device within 30 days before screening or planned during the study period.
- Known hypersensitivity to any components of the investigated solutions.
- Known pregnancy; female patients must be surgically sterile; or postmenopausal for at least two years; or if of childbearing potential must have a negative serum or urine dipstick pregnancy test (if a test result is not available at the time of randomization, a patient may be randomized and treated initially, however, has to be withdrawn immediately from the study as soon as the test result becomes available and is positive).
- Known serum creatinine > 300 μmol/L, corresponding to 3.4 mg/dL (if a serum creatinine value is not available at the time of randomization or an available value is older than 24 hours, a patient may be randomized and treated. If a creatinine value of > 300 μmol/L becomes available later, treatment with the study drug may be continued if the risk/benefit ratio for the individual patient is regarded as positive by the investigator.)
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- Known history of chronic renal failure (hemodialysis)
- Anuria lasting more than 8 hours (<50ml urine output / 8 hours) despite fluid resuscitation prior to randomization.
- Requirement for renal support (either continuous or discontinuous techniques, including intermittent hemodialysis, hemofiltration and hemodiafiltration)
- History of known hemostatic disorders with clinical bleeding (hemophilia and known or suspected Willebrand disease)
- Burns >20% of body surface
- State of brain death
- Known co-morbidities: Hematologic malignant disorders, neutropenia (polymorphonuclear leukocytes [PMN] < 500/mm3), proven liver cirrhosis, Aquired immunodeficiency syndrome (AIDS) Expected requirement for concomitant cancer therapy (e.g. chemotherapradiotherapy or surgery) from randomization until Day 4 Requirement for concomitant cancer therapy (e.g. chemotherapy, radiotherapy or surgery) from randomization until Day 4
- Known fluid overload (EVLWI > 10 ml/kg BW)
- Need for fluid restriction
- Refractory septic shock defined as severe sepsis with hypotension unresponsive to adequate fluid resuscitation, along with the presence of hypoperfusion abnormalities or organ dysfunction as defined by Bone et al., 1992. Patients receiving inotropic or vasopressor agents may no longer be hypotensive by the time they manifest hypoperfusion abnormalities or organ dysfunction, yet they would still be considered to have septic shock. Patients treated with low dose vasopressors are not excluded provided they are responsive to fluid resuscitation as demonstrated by an individual fluid challenge. Patients receiving norepinephrine (noradrenaline) or epinephrine (adrenaline) at a dose > 0.5 μg/kg/min or dopamine at a dose > 15 μg/kg/min at the timepoint of Screening are not eligible for the study.
- Intracranial bleeding
- Any condition rendering a patient unsuitable for inclusion based on the treating physician´s discretion
About this study
Official title: Volume Therapy With Crystalloids and Colloids
The primary alternative hypothesis is that less time (minutes) is required, to achieve the initial hemodynamic stabilization, with Volulyte® compared to Jonosteril®.
- H01: Minutes with Volulyte® ≥ Minutes with Jonosteril®
- H11: Minutes with Volulyte® < Minutes with Jonosteril®
Read the detailed description
Comparative, multicenter, active-controlled, parallel-group, double-blind, randomized study.
Patients who meet the inclusion criteria (at Screening, see below for definition) will be randomized immediately in a ratio of 1:1 to either receive intravenous Volulyte® or Jonosteril® for fluid resuscitation (on RAND). Fluid resuscitation with study drug will be started immediately in order to reach initial hemodynamic stabilization. Assessment of the effects of fluid resuscitation to achieve the primary and secondary endpoints will be performed up to 24 hours following the randomization.
Initial hemodynamic stabilization is defined as normalization of mean arterial pressure (MAP), central venous oxygen saturation (ScvO2) and PPV (pulse pressure variation) or response to PLR (passive leg rising) as defined below and maintaining this normalization over a period of 1 hour, with no increase in the infusion of vasopressors, or inotropic therapy and with ≤ 250ml of additional study drug administration within this 1 hour. The normalization of the parameters MAP and PPV (pulse pressure variation) or PLR (passive leg rising) and ScvO2 is defined as follows:
- MAP: ≥ 65 mmHg
- ScvO2: ≥ 70%
- PPV: ≤ 12% (premise: sinus rhythm, no spontaneous breathing efforts and mechanical ventilation with VT: 5 - < 6 ml/kg).
If PPV is not applicable, response to PLR-manoeuvre is used (see below).
● PLR: < 10% change in cardiac output (CO)
- Conditions
- Severe Sepsis
- Being tested
- Volulyte, Jonosteril
- Keywords
- Haemodynamic stabilization
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VolulyteDrug
Patients who meet the inclusion criteria (at Screening, see below for definition) will be randomized immediately in a ratio of 1:1 to either intravenous Volulyte® or Jonosteril® for fluid resuscitation (on RAND). Fluid resuscitation with study drug will be started immediately in order to reach initial hemodynamic stabilization.
JonosterilDrug
Patients who meet the inclusion criteria (at Screening, see below for definition) will be randomized immediately in a ratio of 1:1 to either intravenous Volulyte® or Jonosteril® for fluid resuscitation (on RAND). Fluid resuscitation with study drug will be started immediately in order to reach initial hemodynamic stabilization.
| Study group | Role | What they receive |
|---|---|---|
| Volulyte | Active comparator | Patients who meet the inclusion criteria (at Screening, see below for definition) will be randomized immediately in a ratio of 1:1 to either intravenous Volulyte® or Jonosteril® for fluid resuscitation (on RAND). Fluid resuscitation with study drug will be started immediately in order to reach initial hemodynamic stabilization. Receives: Drug: Jonosteril |
| Jonosteril | Active comparator | Patients who meet the inclusion criteria (at Screening, see below for definition) will be randomized immediately in a ratio of 1:1 to either intravenous Volulyte® or Jonosteril® for fluid resuscitation (on RAND). Fluid resuscitation with study drug will be started immediately in order to reach initial hemodynamic stabilization. Receives: Drug: Volulyte |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint is defined as the fraction of patients who achieved initial hemodynamic stabilization during the first 6 hours after randomisation.
Measured: During the first 6 hours
Secondary outcomes (1)
Time needed for achievement of initial hemodynamic stabilization during the first 24 hours after randomization.
Measured: during the first 24 hours after randomization.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2015 (estimated)
- Study startMar 2013
- Primary completionJun 2013
- Study completionJun 2013
Why it stopped: treatment substance not labled for sepsis anymore
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe SepsisStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wuerzburg University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02587078
- Sponsor's protocol ID
- 12-VS01-01
- Other IDs
- 2012-000331-30
- Acronym
- VOMOSEP
- Status last verified
- Mar 2016
- First submitted
- 10 Dec 2014
- Last updated
- 30 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Volume Therapy With Crystalloids and Colloids
- ClinicalTrials.gov ID
- NCT02587078
- Acronym / sponsor ID
- VOMOSEP / 12-VS01-01
- Conditions
- Severe Sepsis
- Keywords
- Haemodynamic stabilization
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: treatment substance not labled for sepsis anymore
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Wuerzburg University HospitalUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 27 Oct 2015 (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 primary alternative hypothesis is that less time (minutes) is required, to achieve the initial hemodynamic stabilization, with Volulyte® compared to Jonosteril®.
- H01: Minutes with Volulyte® ≥ Minutes with Jonosteril®
- H11: Minutes with Volulyte® < Minutes with Jonosteril®
Detailed description
Comparative, multicenter, active-controlled, parallel-group, double-blind, randomized study.
Patients who meet the inclusion criteria (at Screening, see below for definition) will be randomized immediately in a ratio of 1:1 to either receive intravenous Volulyte® or Jonosteril® for fluid resuscitation (on RAND). Fluid resuscitation with study drug will be started immediately in order to reach initial hemodynamic stabilization. Assessment of the effects of fluid resuscitation to achieve the primary and secondary endpoints will be performed up to 24 hours following the randomization.
Initial hemodynamic stabilization is defined as normalization of mean arterial pressure (MAP), central venous oxygen saturation (ScvO2) and PPV (pulse pressure variation) or response to PLR (passive leg rising) as defined below and maintaining this normalization over a period of 1 hour, with no increase in the infusion of vasopressors, or inotropic therapy and with ≤ 250ml of additional study drug administration within this 1 hour. The normalization of the parameters MAP and PPV (pulse pressure variation) or PLR (passive leg rising) and ScvO2 is defined as follows:
- MAP: ≥ 65 mmHg
- ScvO2: ≥ 70%
- PPV: ≤ 12% (premise: sinus rhythm, no spontaneous breathing efforts and mechanical ventilation with VT: 5 - < 6 ml/kg).
If PPV is not applicable, response to PLR-manoeuvre is used (see below).
● PLR: < 10% change in cardiac output (CO)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Volulyte | Active comparator | Drug: JonosterilPatients who meet the inclusion criteria (at Screening, see below for definition) will be randomized immediately in a ratio of 1:1 to either intravenous Volulyte® or Jonosteril® for fluid resuscitation (on RAND). Fluid resuscitation with study drug will be started immediately in order to reach initial hemodynamic stabilization. |
| Jonosteril | Active comparator | Drug: VolulytePatients who meet the inclusion criteria (at Screening, see below for definition) will be randomized immediately in a ratio of 1:1 to either intravenous Volulyte® or Jonosteril® for fluid resuscitation (on RAND). Fluid resuscitation with study drug will be started immediately in order to reach initial hemodynamic stabilization. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Prior written informed consent of the patient. If this is not possible, it will be necessary for the investigator to obtain initial informed consent according to the requirements. The legally authorized representative has to provide the written informed consent or in his absence a declaration for inclusion in an emergency situation is to be signed by a consultant physician who is not involved in the study and who is independent of the investigational team. If the patient dies following the inclusion in the clinical trial based on the consulting physician´s vote and no legally authorized representative is available / able to give informed consent, no additional informed consent will be needed and the consultant physician´s vote will be considered sufficient.
- Male or female patient aged 18 years or older
- Presence of severe sepsis defined as:
- Requirement for fluid resuscitation as defined by the measured hemodynamic parameters MAP, ScvO2 and PPV or PLR.
Key exclusion criteria (18 listed)
- Volume expansion with a dosage of HES administered prior to randomization rendering a patient unsuitable for inclusion based on the treating physician´s discretion in consideration of the suggested maximal dose/day.
- Known volume expansion with any dosage of HES 200.000 prior to inclusion during the actual hospital admission.
- Participation in another clinical study with an investigational drug or an investigational medical device within 30 days before screening or planned during the study period.
- Known hypersensitivity to any components of the investigated solutions.
- Known pregnancy; female patients must be surgically sterile; or postmenopausal for at least two years; or if of childbearing potential must have a negative serum or urine dipstick pregnancy test (if a test result is not available at the time of randomization, a patient may be randomized and treated initially, however, has to be withdrawn immediately from the study as soon as the test result becomes available and is positive).
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 |
|---|---|---|
| VolulytePatients who meet the inclusion criteria (at Screening, see below for definition) will be randomized immediately in a ratio of 1:1 to either intravenous Volulyte® or Jonosteril® for fluid resuscitation (on RAND). Fluid resuscitation with study drug will be started immediately in order to reach initial hemodynamic stabilization. | Drug | Jonosteril |
| JonosterilPatients who meet the inclusion criteria (at Screening, see below for definition) will be randomized immediately in a ratio of 1:1 to either intravenous Volulyte® or Jonosteril® for fluid resuscitation (on RAND). Fluid resuscitation with study drug will be started immediately in order to reach initial hemodynamic stabilization. | Drug | Volulyte |
Primary outcome
The primary endpoint is defined as the fraction of patients who achieved initial hemodynamic stabilization during the first 6 hours after randomisation.
Time frame: During the first 6 hours
1 secondary outcome
Time needed for achievement of initial hemodynamic stabilization during the first 24 hours after randomization.
Time frame: during the first 24 hours after randomization.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2016.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Volulyte and Jonosteril in people with Severe Sepsis, run by Wuerzburg University Hospital.
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 16 inclusion and 18 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: withdrawn, as of the sponsor's last update on 30 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
The primary endpoint is defined as the fraction of patients who achieved initial hemodynamic stabilization during the first 6 hours after randomisation. (time frame: During the first 6 hours). 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 30 Nov 2016.