Clinical trial NCT03622099: Small Volume Fluid Challenge as a Predictor of Fluid Responsiveness in Patients With Circulatory Failure
Official title: Transthoracic Echocardiography Guided Small Volume Fluid Challenge as a Predictor of Fluid Responsiveness in Patients With Circulatory Failure: An Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Circulatory Failure
Lead sponsor: Menoufia University
Sponsor class: OTHER
First posted: 2018-08-09
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: in a general adult critical care unit (CCU) at Menoufia University Hospitals

Brief summary: Assessment of intravascular volume status is difficult in critically ill patients. Evidence suggests that only 50% of hemodynamically unstable patients respond to a fluid challenge. Moreover, if cardiopulmonary function cannot compensate for the increase in preload, fluid loading may compromise microvascular perfusion and oxygen delivery and cause or aggravate peripheral and pulmonary edema. Inappropriate fluid expansion can increase morbidity and mortality thus making it important to accurately assess fluid responsiveness in critically ill patients. The volume responsiveness can be defined as a 15% increase in stroke volume (SV) or cardiac output (CO) after a 500-ml infusion. This study tested whether echocardiographic parameters can predict fluid responsiveness in critically ill patients following a low volume 100-ml crystalloid solution infusion over 1 minute.

Detailed description: Fifty-four adult patients with circulatory failure were recruited for the study. As a routine work in adult critical care unit at Menoufia University hospital for patients with circulatory failure, a 100 ml bolus of normal saline solution was given to the patient over 1 minute through a central venous catheter or jugular cannula. For prediction of responders, echocardiographic parameters were recorded1 minute after bolus administration. The remaining 400 ml of normal saline solution was infused at a constant rate over 10 minutes, and echocardiographic parameters were recorded again. The mean echocardiographic measurements over three consecutive respiratory cycles were recorded along with heart rate HR, systolic, diastolic and mean arterial pressures, central venous pressure, and Temperature also mechanical ventilation parameter (tidal volume, respiratory rate and PEEP) for each patient. Patients with an increase in CO after a 100 ml or total 500-ml infusion over 10 minutes (ΔCO500) of 15% or more were classified as responders (Rs) and those without an increase in CO was classified as non-responders

Eligibility criteria: Inclusion Criteria:

* Patients with acute circulatory failure
* Mechanically ventilated \& sedated.(Tidal volume 6-8 ml/ kg, PEEP 5 mmHg, Richmond Agitation-Sedation Scale RASS (R) Score from zero to -3).
* Systemic inflammatory response syndrome
* Septic shock
* Controlled massive hemorrhage

Exclusion Criteria:

* Age of less than 18 years
* Cardiomyopathy
* Pulmonary edema
* Morbid obesity
* Pregnancy
* Increased intracranial tension
* Valvular heart disease
* Myocardial ischemia or infarction before the study

Primary outcomes:
measure: Aortic blood flow velocity Time Integral changes from the baseline
timeFrame: Baseline 10 minutes before start of fluid challenge and1 minute after fluid challenge
Secondary outcomes:
measure: stroke volume change from the baseline
timeFrame: Baseline 10 minutes before start of fluid challenge and1 minute after fluid challenge
measure: cardiac output change from the baseline
timeFrame: Baseline 10 minutes before start of fluid challenge and1 minute after fluid challenge
measure: heart rate change from the baseline
timeFrame: Baseline 10 minutes before start of fluid challenge and1 minute after fluid challenge
measure: systolic blood pressure change from the baseline
timeFrame: Baseline 10 minutes before start of fluid challenge and1 minute after fluid challenge
measure: Diastolic blood pressure change from the baseline
timeFrame: Baseline 10 minutes before start of fluid challenge and1 minute after fluid challenge
measure: Central venous pressure change from the baseline
timeFrame: Baseline 10 minutes before start of fluid challenge and1 minute after fluid challenge
measure: Mean arterial blood pressure change from the baseline
timeFrame: Baseline 10 minutes before start of fluid challenge and1 minute after fluid challenge
measure: Left ventricular end systolic diameter change from the baseline
timeFrame: Baseline 10 minutes before start of fluid challenge and1 minute after fluid challenge
measure: Left ventricular end diastolic diameter change from the baseline
timeFrame: Baseline 10 minutes before start of fluid challenge and1 minute after fluid challenge
measure: Aortic root diameter change from the baseline
timeFrame: Baseline 10 minutes before start of fluid challenge and1 minute after fluid challenge
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Medicine
state: Shebin El-kom
Study officials:
affiliation: Menoufia University
name: Abd-Elazeem A Elbakry, M.D
role: STUDY_CHAIR
References: