SepsisNCT02447042
Minimal Volume for a Fluid Challenge in Septic Patients
A study testing Fluid challenge with crystalloids and Measurement of Pmsf-arm in people with Sepsis, run by St George's, University of London at 1 site in United Kingdom.
Trial summary
The administration of fluids intravenously is the first step in the stabilization of patients in septic shock. It is important to give the right dose of fluids, enough to improve the function of the cardiovascular system but not too much to drown the cells in water. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis
- What is being tested?
- Fluid challenge with crystalloids and Measurement of Pmsf-arm
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Nov 2014to Feb 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
- Fulfil 2 of 4 of the criteria of the systemic inflammatory response syndrome (SIRS) due to known or suspected infection within the previous 24 hours. The SIRS criteria are:
- Core temperature >38 °C or < 36 °C
- Tachycardia (heart rate > 90 beats per minute)
- Tachypnoea (respiratory rate >20 breaths per minute or PaCO2 < 4.3 kPa or need for mechanical ventilation)
- Abnormal white cell count (> 12000 cells/mm3 or < 4000 cells/mm3, or >10% immature (band cells) forms.
Who cannot join
- Extensive peripheral arterial occlusive disease in upper limbs.
- Postoperative valvular insufficiency
- Aortic valve regurgitation
- Tachyarrhythmia
- Cardiac assist device (IntraAortic balloon pump)
- Previously known right ventricular failure
Show all 9Show fewer
- Known vasospastic diseases, systemic sclerosis or Raynaud's phenomenon.
- Patients requiring aggressive fluid resuscitation due to lifethreatening cardiovascular instability
- Known pregnant women.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
St George's University Hospitals, NHS Foundation Trust
London, London, SW17 0QT
About this study
Official title: Study of Changes on Mean Systemic Filling Pressure (Pmsf) and Microcirculation After a Fluid Challenge in Septic Patients: Looking for the Minimal Volume
The administration of fluids intravenously is the first step in the stabilization of patients in septic shock. It is important to give the right dose of fluids, enough to improve the function of the cardiovascular system but not too much to drown the cells in water. In order to know that, the investigators use the "fluid challenge" which is the administration of a "small amount" of fluid in a short period of time in order to test the cardiovascular response to a dose of fluids. However, it is unclear how "small" this amount can be. The aim of this study is to find out the minimum volume required to perform an effective "fluid challenge". The investigators hypothesize that the changes in the mean pressure in the cardiovascular system (socalled mean systemic filling pressure or Pmsf) during the administration of small amounts of fluid can be used to detect the minimum volume required to effectively test the cardiovascular system with a fluid challenge.
On the other hand, microcirculation may remain impaired despite the stabilization of the macrocirculation. The microcirculation can be much more dynamic than the macrocriculation, so it is essential to observe the changes of both over time. Patients admitted at the investigators' intensive care unit (ICU) due to sepsis can be included in this study. The sample will be divided in 4 groups according to the volume of the fluid challenge: 2 ml/kg, 3 ml/kg, 4ml/Kg and 5 ml/kg.
The investigators will measure the Pmsf non-invasively using a pneumatic tourniquet inflated during one minute. Invasive arterial blood pressure will be observed during the inflation of the cuff in the arm to determine the Pmsf. The least significant change of Pmsf using this method is 14%. The minimal volume will be that one that achieve that change in Pmsf.
Read the detailed description
PURPOSE AND DESIGN The main objective of this study is to find out the minimum volume of fluid required to perform an effective "fluid challenge" in septic patients. An effective fluid challenge would be one that is able to increase the mean pressure in the cardiovascular system when there is no blood circulation or socalled the mean systemic filling pressure (Pmsf). It is similar to the pressure into a pneumatic tyre, which is only related to the volume of air and the elastic properties of the tyre wall. In order to do this, the investigators will observe the changes in mean systemic filling pressure after small amounts of fluids so that the investigators will be able to realise how much volume is required to increase that pressure.
To assure that the change in Pmsf is a real change, the investigators have conducted a pilot study in order to determine the precision of the Pmsf measurement using the Pmsf-arm technique. The least significant change is about 14 % from baseline measurement. The Pmsf-arm technique is a process very similar to that the investigators use to measure non-invasive blood pressure. The investigators will measure the arterial-venous equilibrium pressure in the arm after a rapid and brief interruption of blood circulation. In order to do this, a totally noninvasive automatic tourniquet is attached to the arm where the arterial line has been inserted and the tourniquet is inflated during 60 seconds. This process will be done at baseline and after the fluid challenge. The second objective is observe the microcirculation during an affective fluid challenge and correlate the changes observed with the changes in the cardiac function and the Pmsf.
The third objective is to observe the changes generated by the vasoactive therapy in the macro and microcirculation according to the cardiac response and the type of vasoactive therapy used.
In the investigators' clinical practice, the investigators have observed that in some cases the infusion of 250 ml of fluid has no impact at all in the cardiovascular function. The investigators believe that in those cases the investigators may have not given enough fluid to increase the Pmsf and test the cardiovascular response.
RECRUITMENT The sample will be recruited by convenience. It is important to understand the difference between fluid resuscitation and fluid challenge. The fluid resuscitation requires normally large amount of volume in a medical emergency in order to achieve cardiovascular stability. Once the patient is minimally stable, a fluid challenge is normally carried out in order to find out if the patient may benefit from more fluids. As the performance of a fluid challenge is part of the normal clinical practice once the patient has been admitted to ICU, there is minimal extra risk from participation in this study.
CONSENT Informed consent will be required to become participant of this study. Informed consent will be obtained by the Principal Investigator who has also clinical responsibility for the care of patients under the care of the intensive care department. The PI has received training in Good Clinical Practice (GCP).
RISK, BURDENS AND BENEFITS Currently, the investigators use a fluid administration protocol in septic patients based on the principle of "stroke volume maximization". The investigators perform a fluid challenge of about 4 ml/kg until the patient becomes "non-responder", which means that the heart is not able to increase the volume ejected anymore. However, the investigators have observed some pitfalls in this protocol. Some patients classified as "non-responders" may need more than 4 ml/kg to test the cardiovascular response. The investigators' hypothesis is that in those cases, the cardiovascular system is either very relaxed or very empty, and 4 ml/kg was not enough to increase the mean systemic filling pressure. Therefore, a possible benefit associated to this study is to avoid this possible pitfall. If after a fluid challenge the Pmsf has not changed significantly, the clinician in charge will be informed and he/she will decide whether continue with a subsequent fluid challenge until the investigators observe a significant change on Pmsf.
There are not relevant risk from participation in the study. As fluid challenge will be performed in accordance with the clinician prescription, the observations are non-invasive and do not involve any risk for the participant and arterial line is normally used in these patients, there is minimal extra risk from participating in this study.
CONFIDENTIALITY Identifiable data will not be obtained for the purpose of this study. All the data (case report forms and electronic files) will be anonymised. The participant will be identified with a code that will be generated specifically for this study.
The "identification code" generated for the participant will be linked to the "hospital number" and to the name of the patient, by a secret rule that is kept confidentially by the principal researcher. This rule will only be used in case of missing information that can be completed retrospectively. The only person able to access to identifiable information is the principal investigator, who is aware of the responsibility of the confidentiality of this study.
All the data collected will be stored in encrypted electronic memories and the written material in custody of the principal investigator. No written material will contain identifiable data.
CONFLICT OF INTEREST During the period of study, the principal investigator will not be responsible for the participant's care at the same time, in order to avoid conflict of interest. However, the principal investigator retains clinical responsibility for the care of patients as member of the intensive care department.
At the end of the study, the investigators are planning to use this information as a chapter for a doctoral thesis, to present the study in international conferences and, hopefully, to publish the results in scientific journals.
If the patient wishes to be informed of the results of this study, the investigators will send a copy of the abstract presented in international conferences by email, or a copy of the paper accepted in a medical journal by email.
- Conditions
- Sepsis
- Being tested
- Fluid challenge with crystalloids, Measurement of Pmsf-arm
- Keywords
- sepsis, Fluids, Mean systemic filling pressure
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluid challenge with crystalloidsProcedure or surgery
Intravenous infusion of 2, 3, 4 or 5 ml/Kg of crystalloids over 5 minutes.
Measurement of Pmsf-armDevice
Also called Meassurement of mean systemic filling pressure - arm
Measurement of stop-flow arterial-venous equilibrium pressure in the arm where the radial arterial pressure is measured by inflating a pneumatic cuff with an automatic pneumatic tourniquet during 60 seconds before and after the fluid challenge in patients receiving 2 ml/Kg, 3 ml/kg, 4 ml/kg and 5 ml/kg of crystalloids in 5 minutes
| Study group | Role | What they receive |
|---|---|---|
| 2 ml/Kg | Experimental | Fluid challenge with crystalloids (2 ml/Kg) infused in 5 minutes Measurment of Pmsf-arm before and after the fluid challenge Receives: Procedure: Fluid challenge with crystalloids; Device: Measurement of Pmsf-arm |
| 3 ml/Kg | Experimental | Fluid challenge with crystalloids (3 ml/Kg) infused in 5 minutes Measurment of Pmsf-arm before and after the fluid challenge Receives: Procedure: Fluid challenge with crystalloids; Device: Measurement of Pmsf-arm |
| 4 ml/kg | Experimental | Fluid challenge with crystalloids (4 ml/Kg) infused in 5 minutes Measurment of Pmsf-arm before and after the fluid challenge Receives: Procedure: Fluid challenge with crystalloids; Device: Measurement of Pmsf-arm |
| 5 ml/Kg | Experimental | Fluid challenge with crystalloids (5 ml/Kg) infused in 5 minutes Measurment of Pmsf-arm before and after the fluid challenge Receives: Procedure: Fluid challenge with crystalloids; Device: Measurement of Pmsf-arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pmsf-arm (expressed in percentage from baseline value)
Measured: Inmediately after end of fluid infussion
Secondary outcomes (2)
Change in cardiac output (expressed in percentage from baseline value
Measured: Inmmediately after end of fluid infussion
Proportion of responders in each group
Measured: As average three moths after end of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2015 (estimated)
- Study startNov 2014
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- St George's, University of London
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, HollmannAya, St George's, University of London
- Investigators
- Hollmann D Aya, MD, Principal investigator, St George's University Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02447042
- Sponsor's protocol ID
- 14.0156
- Status last verified
- Oct 2016
- First submitted
- 11 May 2015
- Last updated
- 14 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
GUYTON AC. Determination of cardiac output by equating venous return curves with cardiac response curves. Physiol Rev. 1955 Jan;35(1):123-9. doi: 10.1152/physrev.1955.35.1.123. No abstract available.
PubMed 14356924Pinsky MR. Instantaneous venous return curves in an intact canine preparation. J Appl Physiol Respir Environ Exerc Physiol. 1984 Mar;56(3):765-71. doi: 10.1152/jappl.1984.56.3.765.
PubMed 6368503Maas JJ, Geerts BF, van den Berg PC, Pinsky MR, Jansen JR. Assessment of venous return curve and mean systemic filling pressure in postoperative cardiac surgery patients. Crit Care Med. 2009 Mar;37(3):912-8. doi: 10.1097/CCM.0b013e3181961481.
PubMed 19237896
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Changes on Mean Systemic Filling Pressure (Pmsf) and Microcirculation After a Fluid Challenge in Septic Patients: Looking for the Minimal Volume
- ClinicalTrials.gov ID
- NCT02447042
- Acronym / sponsor ID
- 14.0156
- Conditions
- Sepsis
- Keywords
- sepsis, Fluids, Mean systemic filling pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- St George's, University of LondonUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 18 May 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 administration of fluids intravenously is the first step in the stabilization of patients in septic shock. It is important to give the right dose of fluids, enough to improve the function of the cardiovascular system but not too much to drown the cells in water. In order to know that, the investigators use the "fluid challenge" which is the administration of a "small amount" of fluid in a short period of time in order to test the cardiovascular response to a dose of fluids. However, it is unclear how "small" this amount can be. The aim of this study is to find out the minimum volume required to perform an effective "fluid challenge". The investigators hypothesize that the changes in the mean pressure in the cardiovascular system (socalled mean systemic filling pressure or Pmsf) during the administration of small amounts of fluid can be used to detect the minimum volume required to effectively test the cardiovascular system with a fluid challenge.
On the other hand, microcirculation may remain impaired despite the stabilization of the macrocirculation. The microcirculation can be much more dynamic than the macrocriculation, so it is essential to observe the changes of both over time. Patients admitted at the investigators' intensive care unit (ICU) due to sepsis can be included in this study. The sample will be divided in 4 groups according to the volume of the fluid challenge: 2 ml/kg, 3 ml/kg, 4ml/Kg and 5 ml/kg.
The investigators will measure the Pmsf non-invasively using a pneumatic tourniquet inflated during one minute. Invasive arterial blood pressure will be observed during the inflation of the cuff in the arm to determine the Pmsf. The least significant change of Pmsf using this method is 14%. The minimal volume will be that one that achieve that change in Pmsf.
Detailed description
PURPOSE AND DESIGN The main objective of this study is to find out the minimum volume of fluid required to perform an effective "fluid challenge" in septic patients. An effective fluid challenge would be one that is able to increase the mean pressure in the cardiovascular system when there is no blood circulation or socalled the mean systemic filling pressure (Pmsf). It is similar to the pressure into a pneumatic tyre, which is only related to the volume of air and the elastic properties of the tyre wall. In order to do this, the investigators will observe the changes in mean systemic filling pressure after small amounts of fluids so that the investigators will be able to realise how much volume is required to increase that pressure.
To assure that the change in Pmsf is a real change, the investigators have conducted a pilot study in order to determine the precision of the Pmsf measurement using the Pmsf-arm technique. The least significant change is about 14 % from baseline measurement. The Pmsf-arm technique is a process very similar to that the investigators use to measure non-invasive blood pressure. The investigators will measure the arterial-venous equilibrium pressure in the arm after a rapid and brief interruption of blood circulation. In order to do this, a totally noninvasive automatic tourniquet is attached to the arm where the arterial line has been inserted and the tourniquet is inflated during 60 seconds. This process will be done at baseline and after the fluid challenge. The second objective is observe the microcirculation during an affective fluid challenge and correlate the changes observed with the changes in the cardiac function and the Pmsf.
The third objective is to observe the changes generated by the vasoactive therapy in the macro and microcirculation according to the cardiac response and the type of vasoactive therapy used.
In the investigators' clinical practice, the investigators have observed that in some cases the infusion of 250 ml of fluid has no impact at all in the cardiovascular function. The investigators believe that in those cases the investigators may have not given enough fluid to increase the Pmsf and test the cardiovascular response.
RECRUITMENT The sample will be recruited by convenience. It is important to understand the difference between fluid resuscitation and fluid challenge. The fluid resuscitation requires normally large amount of volume in a medical emergency in order to achieve cardiovascular stability. Once the patient is minimally stable, a fluid challenge is normally carried out in order to find out if the patient may benefit from more fluids. As the performance of a fluid challenge is part of the normal clinical practice once the patient has been admitted to ICU, there is minimal extra risk from participation in this study.
CONSENT Informed consent will be required to become participant of this study. Informed consent will be obtained by the Principal Investigator who has also clinical responsibility for the care of patients under the care of the intensive care department. The PI has received training in Good Clinical Practice (GCP).
RISK, BURDENS AND BENEFITS Currently, the investigators use a fluid administration protocol in septic patients based on the principle of "stroke volume maximization". The investigators perform a fluid challenge of about 4 ml/kg until the patient becomes "non-responder", which means that the heart is not able to increase the volume ejected anymore. However, the investigators have observed some pitfalls in this protocol. Some patients classified as "non-responders" may need more than 4 ml/kg to test the cardiovascular response. The investigators' hypothesis is that in those cases, the cardiovascular system is either very relaxed or very empty, and 4 ml/kg was not enough to increase the mean systemic filling pressure. Therefore, a possible benefit associated to this study is to avoid this possible pitfall. If after a fluid challenge the Pmsf has not changed significantly, the clinician in charge will be informed and he/she will decide whether continue with a subsequent fluid challenge until the investigators observe a significant change on Pmsf.
There are not relevant risk from participation in the study. As fluid challenge will be performed in accordance with the clinician prescription, the observations are non-invasive and do not involve any risk for the participant and arterial line is normally used in these patients, there is minimal extra risk from participating in this study.
CONFIDENTIALITY Identifiable data will not be obtained for the purpose of this study. All the data (case report forms and electronic files) will be anonymised. The participant will be identified with a code that will be generated specifically for this study.
The "identification code" generated for the participant will be linked to the "hospital number" and to the name of the patient, by a secret rule that is kept confidentially by the principal researcher. This rule will only be used in case of missing information that can be completed retrospectively. The only person able to access to identifiable information is the principal investigator, who is aware of the responsibility of the confidentiality of this study.
All the data collected will be stored in encrypted electronic memories and the written material in custody of the principal investigator. No written material will contain identifiable data.
CONFLICT OF INTEREST During the period of study, the principal investigator will not be responsible for the participant's care at the same time, in order to avoid conflict of interest. However, the principal investigator retains clinical responsibility for the care of patients as member of the intensive care department.
At the end of the study, the investigators are planning to use this information as a chapter for a doctoral thesis, to present the study in international conferences and, hopefully, to publish the results in scientific journals.
If the patient wishes to be informed of the results of this study, the investigators will send a copy of the abstract presented in international conferences by email, or a copy of the paper accepted in a medical journal by email.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 2 ml/Kg | Experimental | Procedure: Fluid challenge with crystalloids, Device: Measurement of Pmsf-armFluid challenge with crystalloids (2 ml/Kg) infused in 5 minutes Measurment of Pmsf-arm before and after the fluid challenge |
| 3 ml/Kg | Experimental | Procedure: Fluid challenge with crystalloids, Device: Measurement of Pmsf-armFluid challenge with crystalloids (3 ml/Kg) infused in 5 minutes Measurment of Pmsf-arm before and after the fluid challenge |
| 4 ml/kg | Experimental | Procedure: Fluid challenge with crystalloids, Device: Measurement of Pmsf-armFluid challenge with crystalloids (4 ml/Kg) infused in 5 minutes Measurment of Pmsf-arm before and after the fluid challenge |
| 5 ml/Kg | Experimental | Procedure: Fluid challenge with crystalloids, Device: Measurement of Pmsf-armFluid challenge with crystalloids (5 ml/Kg) infused in 5 minutes Measurment of Pmsf-arm before and after the fluid challenge |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Fulfil 2 of 4 of the criteria of the systemic inflammatory response syndrome (SIRS) due to known or suspected infection within the previous 24 hours. The SIRS criteria are:
- Core temperature >38 °C or < 36 °C
- Tachycardia (heart rate > 90 beats per minute)
- Tachypnoea (respiratory rate >20 breaths per minute or PaCO2 < 4.3 kPa or need for mechanical ventilation)
- Abnormal white cell count (> 12000 cells/mm3 or < 4000 cells/mm3, or >10% immature (band cells) forms.
Key exclusion criteria (9 listed)
- Extensive peripheral arterial occlusive disease in upper limbs.
- Postoperative valvular insufficiency
- Aortic valve regurgitation
- Tachyarrhythmia
- Cardiac assist device (IntraAortic balloon pump)
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 |
|---|---|---|
| Fluid challenge with crystalloidsIntravenous infusion of 2, 3, 4 or 5 ml/Kg of crystalloids over 5 minutes. | Procedure or surgery | 2 ml/Kg, 3 ml/Kg, 4 ml/kg, 5 ml/Kg |
| Measurement of Pmsf-armAlso: Meassurement of mean systemic filling pressure - armMeasurement of stop-flow arterial-venous equilibrium pressure in the arm where the radial arterial pressure is measured by inflating a pneumatic cuff with an automatic pneumatic tourniquet during 60 seconds before and after the fluid challenge in patients receiving 2 ml/Kg, 3 ml/kg, 4 ml/kg and 5 ml/kg of crystalloids in 5 minutes | Device | 2 ml/Kg, 3 ml/Kg, 4 ml/kg, 5 ml/Kg |
Primary outcome
Change in Pmsf-arm (expressed in percentage from baseline value)
Time frame: Inmediately after end of fluid infussion
2 secondary outcomes
Change in cardiac output (expressed in percentage from baseline value
Time frame: Inmmediately after end of fluid infussion
Proportion of responders in each group
Time frame: As average three moths after end of the study
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 Oct 2016.
- Background: PubMed 14356924GUYTON AC. Determination of cardiac output by equating venous return curves with cardiac response curves. Physiol Rev. 1955 Jan;35(1):123-9. doi: 10.1152/physrev.1955.35.1.123. No abstract available.
- Background: PubMed 6368503Pinsky MR. Instantaneous venous return curves in an intact canine preparation. J Appl Physiol Respir Environ Exerc Physiol. 1984 Mar;56(3):765-71. doi: 10.1152/jappl.1984.56.3.765.
- Background: PubMed 19237896Maas JJ, Geerts BF, van den Berg PC, Pinsky MR, Jansen JR. Assessment of venous return curve and mean systemic filling pressure in postoperative cardiac surgery patients. Crit Care Med. 2009 Mar;37(3):912-8. doi: 10.1097/CCM.0b013e3181961481.
- Individual participant dataSharing planned: No
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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.
Hollmann D Aya, MD principal investigator
St George's University Hospitals NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fluid challenge with crystalloids and Measurement of Pmsf-arm in people with Sepsis, run by St George's, University of London at 1 site in United Kingdom.
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 5 inclusion and 9 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 Oct 2016. 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 United Kingdom. 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?
Change in Pmsf-arm (expressed in percentage from baseline value) (time frame: Inmediately after end of fluid infussion). 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 NCT02447042, which also lists 3 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 14 Oct 2016.