HypotensionNCT00721604
Fluid Responsiveness Prediction at the Bedside
An observational study of Hypotension and Shock, run by Fondazione Poliambulanza Istituto Ospedaliero at 1 site in Italy.
Trial summary
The purpose of this study is to verify the accuracy and applicability of predictors of fluid administration efficacy in hypotensive critically ill patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypotension, Shock
- What is being tested?
- fluid administration
- Type of treatment
- Injection or infusion
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- Jul 2008to May 2009
- Phase
- Observational
- 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
Study population: Hypotensive patients in a General Intensive Care Unit of a University-affiliated hospital. Patients can be recruited only if they have both arterial and central venous catheters
Who may be able to join
- mean arterial pressure lower than 65 mmHg
Who cannot join
- fluid overload
- mean arterial pressure lower than 45 mmHg and mandatory immediate treatment
- active bleeding
- hemoglobin lower than 8 g.dl-1
Trial locations and contacts
1 site in 1 country.
Italy1 site
Intensive Care Unit, Fondazione Poliambulanza Istituto Ospedaliero
Brescia, 25124
About this study
Official title: Prediction of Volume Expansion Effectiveness in Hypotensive Critically Ill Patients.
The purpose of this study is to verify the accuracy and applicability of predictors of fluid administration efficacy in hypotensive critically ill patients.
Read the detailed description
Severe hypotension is a common life-threatening conditions in critically ill patients. Discriminating between the need for volume expansion or inotropic/vasoactive support is a main clinical goal. Pulse pressure variation are an accurate index of fluid responsiveness, but it needs controlled mechanical ventilation with a tidal volume of at least 8 ml/kg and absence of arrhythmias. This could limit its clinical applicability. Moreover pulse pressure variation accurately predicted cardiac output increment. However the cardiac output increase is not a clinically relevant target in absence of low cardiac output.
The objectives of the present protocol are: 1) to calculate the accuracy of cardiovascular and renal variables to predict either arterial pressure increase or clinically relevant improvement after fluid administration and 2) to verify how often dynamic indices could be applied in clinical practice.
Arterial pressure increase is defined by mean arterial pressure above 65 mmHg or an increment greater than 20 % respect to basal value. Clinically relevant improvement is defined by restoring adequate values of arterial pressure or cardiac index or diuresis or central venous saturation if they are inadequate before fluid administration. These adequate values are 65 mmHg for mean arterial pressure, 2.5 l.min-1.m-2 for cardiac index, 0.5 ml.kg-1.h-1 for the diuresis, 70 % for central venous saturation.
- Conditions
- Hypotension, Shock
- Being tested
- fluid administration
- Keywords
- shock, fluid responsiveness, volume expansion
- Medical subject headings
- Hypotension, Shock
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fluid administrationDrug
Also called Haes Steril, Fresenius Kabi
two consecutive infusions of 6% hydroxyethyl starch at the dosage 7 ml/kg over 30 minutes (total 14 ml/kg in 60 minutes)
| Study group | Role | What they receive |
|---|---|---|
| 1 | patients with mean arterial pressure lower than 65 mmHg Receives: Drug: fluid administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
area under ROC curve of pulse pressure variation before volume expansion and their positive and negative predictive values; responders are patients increasing mean arterial pressure
Measured: one hour after the end of fluid administration
Secondary outcomes (13)
area under ROC curve of pulse plethysmographic variation before volume expansion and their positive and negative predictive values; responders are patients increasing mean arterial pressure
Measured: one hour after the end of fluid administration
area under ROC curve of pulse pressure variation before volume expansion, positive and negative predictive values; responders are patients showing any clinical improvement
Measured: one hour after the end of fluid administration
area under ROC curve of pulse plethysmographic variation before volume expansion, positive and negative predictive values; responders are patients showing any clinical improvement
Measured: one hour after the end of fluid administration
area under ROC curve of central venous pressure before volume expansion and their positive and negative predictive values; responders are patients increasing mean arterial pressure
Measured: one hour after the end of fluid administration
area under ROC curve of central venous pressure before volume expansion, positive and negative predictive values; responders are patients showing any clinical improvement
Measured: one hour after the end of fluid administration
area under ROC curve of central venous saturation before volume expansion, positive and negative predictive values; responders are patients showing any clinical improvement
Measured: one hour after the end of fluid administration
area under ROC curve of central-arterial PCO2 pressure difference before volume expansion, positive and negative predictive values; responders are patients showing any clinical improvement
Measured: one hour after the end of fluid administration
area under ROC curve of arterial lactate before volume expansion, positive and negative predictive values; responders are patients showing any clinical improvement
Measured: one hour after the end of fluid administration
area under ROC curve of fractional excretion of sodium before volume expansion, positive and negative predictive values; responders are patients showing any clinical improvement
Measured: one hour after the end of fluid administration
area under ROC curve of sodium/potassium urinary ratio before volume expansion, positive and negative predictive values; responders are patients showing any clinical improvement
Measured: one hour after the end of fluid administration
comparison between the number of patients with criteria for pulse pressure variation calculation and the number of patients with other predictive variables
Measured: one hour after the end of fluid administration
estimation of variables independently associated to arterial pressure increase
Measured: one hour after the end of fluid administration
estimation of variables independently associated to clinically relevant improvement
Measured: one hour after the end of fluid administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2008 (estimated)
- Study startJul 2008
- Primary completionApr 2009
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypotensionStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione Poliambulanza Istituto Ospedaliero
- Sponsor type
- University, hospital or other
- Investigators
- Giuseppe Natalini, MD, Principal investigator, Fondazione Poliambulanza Istituto Ospedaliero
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00721604
- Sponsor's protocol ID
- FP-TIP-03
- Status last verified
- Jul 2009
- First submitted
- 22 Jul 2008
- Last updated
- 3 Aug 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Natalini G, Rosano A, Militano CR, Di Maio A, Ferretti P, Bertelli M, de Giuli F, Bernardini A. Prediction of arterial pressure increase after fluid challenge. BMC Anesthesiol. 2012 Mar 5;12:3. doi: 10.1186/1471-2253-12-3.
PubMed 22390818
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Volume Expansion Effectiveness in Hypotensive Critically Ill Patients.
- ClinicalTrials.gov ID
- NCT00721604
- Acronym / sponsor ID
- FP-TIP-03
- Conditions
- Hypotension, Shock
- Keywords
- shock, fluid responsiveness, volume expansion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Fondazione Poliambulanza Istituto OspedalieroUniversity, hospital or other
- Study start
- Jul 2008
- Primary completion
- Apr 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 24 Jul 2008 (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 is to verify the accuracy and applicability of predictors of fluid administration efficacy in hypotensive critically ill patients.
Detailed description
Severe hypotension is a common life-threatening conditions in critically ill patients. Discriminating between the need for volume expansion or inotropic/vasoactive support is a main clinical goal. Pulse pressure variation are an accurate index of fluid responsiveness, but it needs controlled mechanical ventilation with a tidal volume of at least 8 ml/kg and absence of arrhythmias. This could limit its clinical applicability. Moreover pulse pressure variation accurately predicted cardiac output increment. However the cardiac output increase is not a clinically relevant target in absence of low cardiac output.
The objectives of the present protocol are: 1) to calculate the accuracy of cardiovascular and renal variables to predict either arterial pressure increase or clinically relevant improvement after fluid administration and 2) to verify how often dynamic indices could be applied in clinical practice.
Arterial pressure increase is defined by mean arterial pressure above 65 mmHg or an increment greater than 20 % respect to basal value. Clinically relevant improvement is defined by restoring adequate values of arterial pressure or cardiac index or diuresis or central venous saturation if they are inadequate before fluid administration. These adequate values are 65 mmHg for mean arterial pressure, 2.5 l.min-1.m-2 for cardiac index, 0.5 ml.kg-1.h-1 for the diuresis, 70 % for central venous saturation.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Drug: fluid administrationpatients with mean arterial pressure lower than 65 mmHg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hypotensive patients in a General Intensive Care Unit of a University-affiliated hospital. Patients can be recruited only if they have both arterial and central venous catheters
Key inclusion criteria (1 listed)
- mean arterial pressure lower than 65 mmHg
Key exclusion criteria (4 listed)
- fluid overload
- mean arterial pressure lower than 45 mmHg and mandatory immediate treatment
- active bleeding
- hemoglobin lower than 8 g.dl-1
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 administrationAlso: Haes Steril, Fresenius Kabitwo consecutive infusions of 6% hydroxyethyl starch at the dosage 7 ml/kg over 30 minutes (total 14 ml/kg in 60 minutes) | Drug | 1 |
Primary outcome
area under ROC curve of pulse pressure variation before volume expansion and their positive and negative predictive values; responders are patients increasing mean arterial pressure
Time frame: one hour after the end of fluid administration
13 secondary outcomes
area under ROC curve of pulse plethysmographic variation before volume expansion and their positive and negative predictive values; responders are patients increasing mean arterial pressure
Time frame: one hour after the end of fluid administration
area under ROC curve of pulse pressure variation before volume expansion, positive and negative predictive values; responders are patients showing any clinical improvement
Time frame: one hour after the end of fluid administration
area under ROC curve of pulse plethysmographic variation before volume expansion, positive and negative predictive values; responders are patients showing any clinical improvement
Time frame: one hour after the end of fluid administration
area under ROC curve of central venous pressure before volume expansion and their positive and negative predictive values; responders are patients increasing mean arterial pressure
Time frame: one hour after the end of fluid administration
area under ROC curve of central venous pressure before volume expansion, positive and negative predictive values; responders are patients showing any clinical improvement
Time frame: one hour after the end of fluid administration
area under ROC curve of central venous saturation before volume expansion, positive and negative predictive values; responders are patients showing any clinical improvement
Time frame: one hour after the end of fluid administration
area under ROC curve of central-arterial PCO2 pressure difference before volume expansion, positive and negative predictive values; responders are patients showing any clinical improvement
Time frame: one hour after the end of fluid administration
area under ROC curve of arterial lactate before volume expansion, positive and negative predictive values; responders are patients showing any clinical improvement
Time frame: one hour after the end of fluid administration
area under ROC curve of fractional excretion of sodium before volume expansion, positive and negative predictive values; responders are patients showing any clinical improvement
Time frame: one hour after the end of fluid administration
area under ROC curve of sodium/potassium urinary ratio before volume expansion, positive and negative predictive values; responders are patients showing any clinical improvement
Time frame: one hour after the end of fluid administration
comparison between the number of patients with criteria for pulse pressure variation calculation and the number of patients with other predictive variables
Time frame: one hour after the end of fluid administration
estimation of variables independently associated to arterial pressure increase
Time frame: one hour after the end of fluid administration
estimation of variables independently associated to clinically relevant improvement
Time frame: one hour after the end of fluid administration
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 3 Aug 2009.
- Derived from this study: PubMed 22390818Natalini G, Rosano A, Militano CR, Di Maio A, Ferretti P, Bertelli M, de Giuli F, Bernardini A. Prediction of arterial pressure increase after fluid challenge. BMC Anesthesiol. 2012 Mar 5;12:3. doi: 10.1186/1471-2253-12-3.
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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.
Giuseppe Natalini, MD principal investigator
Fondazione Poliambulanza Istituto Ospedaliero
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypotension and Shock, run by Fondazione Poliambulanza Istituto Ospedaliero at 1 site in Italy.
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 1 inclusion and 4 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 3 Aug 2009. 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 Italy. 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?
area under ROC curve of pulse pressure variation before volume expansion and their positive and negative predictive values; responders are patients increasing mean arterial pressure (time frame: one hour after the end of fluid administration). 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 NCT00721604, which also lists 1 linked publication.
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 3 Aug 2009.