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Completed

NCT Number: NCT03622099

Small Volume Fluid Challenge as a Predictor of Fluid Responsiveness in Patients With Circulatory Failure

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Faculty of Medicine

Cairo, Shebin El-kom, 32511, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Normal Saline Flush, 0.9% Injectable Solution

Drug

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 Flush, 0.9% Injectable Solution was given to the patient over 1 minute through a central venous catheter or jugular cannula. For prediction of responders, echocardiographic parameters measured followed by infusion of the remaining 400 ml of Normal Saline Flush, 0.9% Injectable Solution at a constant rate over 10 minutes then echocardiographic parameters measured again to detect the patient response.

Other names: normal saline

Primary outcomes

  1. Aortic blood flow velocity Time Integral changes from the baseline

    Time frame: Baseline 10 minutes before start of fluid challenge and1 minute after fluid challenge

    [cm]

Secondary outcomes

  1. stroke volume change from the baseline

    Time frame: Baseline 10 minutes before start of fluid challenge and1 minute after fluid challenge

    [ml/beat]

  2. cardiac output change from the baseline

    Time frame: Baseline 10 minutes before start of fluid challenge and1 minute after fluid challenge

    [ liter/minute]

  3. heart rate change from the baseline

    Time frame: Baseline 10 minutes before start of fluid challenge and1 minute after fluid challenge

    [beats/minute]

  4. systolic blood pressure change from the baseline

    Time frame: Baseline 10 minutes before start of fluid challenge and1 minute after fluid challenge

    [mmHg]

  5. Diastolic blood pressure change from the baseline

    Time frame: Baseline 10 minutes before start of fluid challenge and1 minute after fluid challenge

    [mmHg]

  6. Central venous pressure change from the baseline

    Time frame: Baseline 10 minutes before start of fluid challenge and1 minute after fluid challenge

    [Cm water]

  7. Mean arterial blood pressure change from the baseline

    Time frame: Baseline 10 minutes before start of fluid challenge and1 minute after fluid challenge

    [mmHg]

  8. Left ventricular end systolic diameter change from the baseline

    Time frame: Baseline 10 minutes before start of fluid challenge and1 minute after fluid challenge

    [Cm]

  9. Left ventricular end diastolic diameter change from the baseline

    Time frame: Baseline 10 minutes before start of fluid challenge and1 minute after fluid challenge

    [Cm]

  10. Aortic root diameter change from the baseline

    Time frame: Baseline 10 minutes before start of fluid challenge and1 minute after fluid challenge

    [Cm]

Sponsors and collaborators

Lead sponsor

Menoufia University

Other

Registry information

Official study title

Transthoracic Echocardiography Guided Small Volume Fluid Challenge as a Predictor of Fluid Responsiveness in Patients With Circulatory Failure: An Observational Study

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Aug 9, 2018
Registry last updated
Apr 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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