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Breathing patterns may skew Fluid-Readiness test in ICU shock patients

NCT ID NCT07644494

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Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
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Stopped early
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Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

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Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

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Status unknown
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First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at 50 shock patients on ventilators to see if their breathing effort changes the accuracy of an ultrasound test that measures a large vein in the belly. Doctors used the test to predict whether giving fluids would help the heart pump more blood. They found that how hard a patient breathes can affect the test's reliability, which may help doctors make better fluid decisions in the ICU.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

50 people

The number who actually took part.

Started

Jun 2024

Finished

May 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

This prospective observational study was conducted in an intensive care unit of a university hospital and included shock patients receiving ventilation with spontaneous breathing activity

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. defined as shock who has the presence of systolic blood pressure (SBP) ≤ 90 or a \> 40 mmHg decline of SBP in patients known to be hypertensive or mean arterial pressure (MAP) ≤ 70 mmHg or requiring vasopressors to maintain SBP \> 90 mmHg or MAP \> 70 mmHg, along with signs of hypoperfusion (urinary flow \< 0.5 ml/kg/min for \> 2 h, or presence of skin mottling or blood lactate concentration ≥ 2.0 mmol/L); 2. received mechanical ventilation; 3. had the Pulse Indicator Continuous Cardiac Output (PiCCO) catheter for hemodynamic monitoring; 4. had the sign of fluid administration which include: (a) MAP \< 65 mmHg and/or SBP \< 90 mmHg; (b) the need for vasopressors; (c) urinary flow \< 0.5 ml/kg/min for \>2 h; (d) tachycardia; (e) lactic acidosis; or (f) delayed capillary refilling. Exclusion Criteria: 1. were pregnant; 2. were younger than 18 years of age; 3. could not have spontaneous respiratory drive or effort measured; 4. had intra-abdominal pressure ≥ 16 cmH₂O \[15\]; 5. had conditions affecting dIVC measurement, such as ECMO cannulation; 6. had factors precluding clear ultrasound imaging; 7. defined as right ventricular dysfunction who has (a) tricuspid annular plane systolic excursion \< 16 mm; (b) moderate or greater tricuspid regurgitation; (c) moderate or greater pulmonary artery hypertension\[16\]; 8. expected to die within 24 hours; 9. had family members of the patient declined enrollment.

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Conditions

The condition(s) this trial relates to.

Shock

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Zhongda hospital

    Nanjing, Jiangsu, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.