S wave variability to assess fluid responsiveness in critically ill patients: a pilot trial.

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12616001431415

Enrollment

Registered

2016-10-13

Start date

2017-01-01

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This prospective pilot trial aims to investigate the reliability of a non invasive hemodynamic parameter obtained by means of tissue doppler in critically ill patients. In particular, the s wave is related to the systolic function of both right and left ventricles. The purpose of the study is to investigate the sensitivity and specificity of s wave variability, compared to the gold standard of pulse pressure variation (PPV) - a non invasive parameter measured by many different hemodynamic monitors- in assessing the fluid responsiveness. Fluid responsiveness is defined as the ability of increasing the cardiac index after a infusion of a standard amount of fluids (500 ml of crystalloids in 30 minutes, fluid challenge). The study protocol consists in 4 steps: 1) enrollment of patients who need fluid resuscitation (see inclusion criteria) and already monitored with a tool measuring PPV 2) echocardiographic evaluation of s waves (both right and left) 3) fluid challenge administration 4) data analysis

Interventions

Tissue doppler performed before and at the end of fluid administration, to assess S wave variability Pulse pressure variation measured before and at the end of fluid administration Fluid administration consists in a single administration of 500 ml of intravenous crystalloids in 10 minutes.

Study design

Allocation

Non-randomised trial

Primary purpose

Diagnosis

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Critically ill patients with an acute circulatory failure under conventional mechanical ventilation for whom the attending clinician had decided to administer fluid. This decision is based on the presence of at least one clinical sign of inadequate tissue perfusion in the absence of contraindication for fluid infusion. Clinical signs of inadequate tissue perfusion are defined as 1) systolic blood pressure 90 mm Hg (or a decrease 50 mm Hg in previously hypertensive patients) or the need of vasopressive drugs (dopamine 5 mcg/kg/min or norepinephrine), 2) urine output 0.5 mL/kg/hr for at least 2 hrs, 3) tachycardia (heart rate HR 100/min) 4) presence of skin mottling

Exclusion criteria

1) cardiac arrhythmias of any type. 2) moderate to severe ARDS 3) moderate to severe valvulopathies 4) inadequate acoustic window

Outcome results