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Fluid ReponsivenessNCT03413657

Predicting Fluid Responsiveness Using Transiently Increased Intrathoracic Pressure in Mechanically Ventilated Patients

A study testing Increase in intrathoracic pressure in people with Fluid Reponsiveness, run by University of California, Davis at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The goal of this study is to identify in patients requiring active fluid resuscitation and mechanical ventilation for circulatory shock, can a controlled increase in intrathoracic pressure (either by positive-end expiratory pressure (PEEP) or tidal volume (TV)) predict responsiveness to additional fluid resuscitation. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Fluid Reponsiveness
What is being tested?
Increase in intrathoracic pressure
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
5 participants
Where
1 siteUnited States
Study dates
27 Dec 2017to 13 Sep 2018
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

  • Mechanically ventilated
  • Identified by treatment team as requiring intravenous fluid bolus
  • Acute circulatory failure during admission (systolic blood pressure (SBP) ≤90 mmHg or mean arterial pressure (MAP) ≤70 mmHg or requiring vasopressors to maintain SBP >90 mmHg or MAP >70 mmHg, along with one or more of the following:
  • urinary flow ≤0.5 mL/kg/min for ≥2 hours,
  • heart rate ≥100 beats per minute
  • presence of skin mottling
  • blood lactate concentration ≥4 mmol/L

Who cannot join

  • Contraindication to fluid bolus
  • Assynchrony Index > 10%
  • Clinically significant cardiac arrhythmia
  • Severe valvular heart disease
  • Chest tubes with air leak
  • Abdominal compartment syndrome
Show all 12Show fewer
  • Pregnancy
  • Concurrent nebulized medication or inhaled nitric oxide
  • Transthoracic echogenicity unsuitable for measuring velocity-time integral of aortic blood flow (SVI)
  • Prisoner
  • Clinical brain death
  • PEEP > 15 cmH2O

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of California, Davis

    Sacramento, California, 95817

Other trials in United States

About this study

The goal of this study is to identify in patients requiring active fluid resuscitation and mechanical ventilation for circulatory shock, can a controlled increase in intrathoracic pressure (either by positive-end expiratory pressure (PEEP) or tidal volume (TV)) predict responsiveness to additional fluid resuscitation.

We hypothesize that a temporary, physiologically-safe increase in positive-end expiratory pressure (PEEP) and/or a temporary increase in tidal volume (from 6 cc/kg predicted body weight (PBW) to 8 cc/kg PBW) in patients requiring invasive mechanical ventilation will predict fluid responsiveness based upon an assessment of the change in pulse pressure and stroke volume variation.

Read the detailed description

Once an eligible subject is identified and written or telephone consent is obtained from the patient or surrogate as appropriate, we will record demographic data and clinical information including age, sex, height, actual body weight, predicted body weight (PBW), APACHE II on admission, primary diagnosis, reason for ICU admission, and dose of vasopressors.

Patients will be intubated and on assist-control volume ventilation receiving low tidal volumes. Sedation will be titrated per current MICU protocol to minimize patient discomfort and minimizing ventilator dyssynchrony. In keeping with standard practice, the dose of vasoactive medications will be kept constant during the intervention period. The standard practice is to titrate vasopressor therapy every five minutes, so keeping vasoactive medications constant for sixty seconds is in keeping with the standard of care. All subjects will be in an ICU setting and monitored per standard of care (vital signs, telemetry, ventilator data) by a respiratory therapist, pulmonary and critical care fellow or faculty member, and critical care nurse at the bedside throughout the entire intervention.

A point of care (POC) echocardiogram will be performed by the investigator performing the intervention in order to measure the stroke volume index (surrogate for cardiac output).

Subjects will be randomized to either undergo the PEEP challenge or tidal volume challenge first. After the initial challenge, subjects will cross over to whichever challenge has not yet been performed.

The simple changes to the ventilator we are proposing to use as challenges in this study are done frequently and routinely in the ICU with or without the supervision of a physician, but we will have a physician present throughout the entire proposed intervention. For the subjects undergoing PEEP challenge first, we will do the following:

  1. POC echocardiogram performed to measure SVI
  2. The tidal volume will be set to 6 mL/kg PBW and the patients will be monitored for 5 minutes for any variability in vital parameters. The subject's ventilatory parameters, vitals, hemodynamics, and oxygenation will be recorded on initial ventilator settings.
  3. PEEP challenge - PEEP will be increased by 50% for 60 seconds. The subject's ventilatory parameters, vitals, hemodynamics, and oxygenation will be recorded after 60 seconds.
  4. PEEP returned to initial settings.
  5. 2 minute washout period to prepare for tidal volume challenge.
  6. Tidal volume challenge - tidal volume raised to 8 cc/kg PBW for 60 seconds. The subject's ventilatory parameters, vitals, hemodynamics, and oxygenation will be recorded will be recorded after 60 seconds.
  7. Subjects ventilator settings returned to initial settings x 2 minutes.
  8. 500 cc crystalloid fluid bolus of the ICU team's choosing is then administered to the patient. The subject's ventilatory parameters, vitals, hemodynamics, and oxygenation will be measured.
  9. POC echocardiogram performed to measure SVI and determine if the subject is a fluid responder or non-responder.

The procedure for those randomized into the tidal volume challenge first will be similar, but the tidal volume challenge (e, above), rather than the PEEP challenge (b, above), will be performed first.

In the management of a critically ill patient in circulatory shock, physicians encounter the question of whether to administer fluid to the patient or not several times during the course of the patient's stay in the ICU. To ensure that our study is generalizable and applicable, we will perform the above protocol up to three times per subject. This is similar to previous studies using changes in intrathoracic pressure to predict fluid responsiveness. Additionally, we will have a larger number of interventions in order to better show a clear difference statistically.

Being tested
Increase in intrathoracic pressure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Increase in intrathoracic pressureProcedure or surgery

    Also called PEEP Challenge, Tidal Volume Challenge

    Will transiently increase intrathoracic pressure for 60 seconds and monitor for changes in hemodynamics during this time.

Study groups in NCT03413657
Study groupRoleWhat they receive
Fluid respondersOtherPatient's identified to have a significant increase in their cardiac output following a fluid bolus.
Receives: Procedure: Increase in intrathoracic pressure
Fluid non-respondersOtherPatient's identified to NOT have a significant increase in their cardiac output following a fluid bolus.
Receives: Procedure: Increase in intrathoracic pressure

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pulse Pressure Variation

    Temporary increase in intrathoracic pressure (PEEP or TV) will predict fluid responsiveness using an absolute increase in pulse pressure variation by 3% or more.

    Measured: Following 60 seconds of intrathoracic pressure challenge

Secondary outcomes (5)
  1. Heart Rate

    Temporary increase in intrathoracic pressure (PEEP or TV) will predict fluid responsiveness using an absolute decrease in heart rate by 15 beats per minute or more.

    Measured: Following 60 seconds of intrathoracic pressure challenge

  2. Mean Arterial Pressure

    Temporary increase in intrathoracic pressure (PEEP or TV) will predict fluid responsiveness using an absolute decrease in MAP by 15 mmHg or more.

    Measured: Following 60 seconds of intrathoracic pressure challenge

  3. Mortality

    Differences in 7 day mortality between fluid responders and non-responders

    Measured: 7 days

  4. Stroke Volume Variation

    Temporary increase in intrathoracic pressure (PEEP or TV) will predict fluid responsiveness using an absolute increase in SVV of 4% or more.

    Measured: Following 60 seconds of intrathoracic pressure challenge

  5. End-tidal carbon dioxide

    Temporary increase in intrathoracic pressure (PEEP or TV) will predict fluid responsiveness using an increase in EtCO2 by 4% or more.

    Measured: Following 60 seconds of intrathoracic pressure challenge

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jan 2018
  2. Study start27 Dec 2017
  3. Primary completion13 Sep 2018
  4. Study completion13 Sep 2018

Resources

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
Crossover
Model description
Subjects will be randomized to either undergo the PEEP challenge or tidal volume challenge first. After the initial challenge, subjects will cross over to whichever challenge has not yet been performed. Subjects will be separated into the following categories: "fluid responders" and "non-responders" and analyzed in those categories.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
5 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03413657
Sponsor's protocol ID
1086731
Status last verified
Jan 2020
First submitted
11 Jan 2018
Last updated
18 Jan 2020
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Increase in intrathoracic pressure in people with Fluid Reponsiveness, run by University of California, Davis at 1 site in United States.

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 7 inclusion and 12 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 18 Jan 2020. 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 States. 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?

Pulse Pressure Variation (time frame: Following 60 seconds of intrathoracic pressure challenge). 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 18 Jan 2020.

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