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

NCT ID: NCT03622099

Last Updated: 2019-04-25

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 54 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-09-07
• Study Completion Date: 2019-02-26

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

Conditions

Circulatory Failure

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

The study group

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.

Normal Saline Flush, 0.9% Injectable Solution

Intervention Type: 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.

Interventions

Normal Saline Flush, 0.9% Injectable Solution

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.

Intervention Type: DRUG

Other Intervention Names

normal saline

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Menoufia University

OTHER

Sponsor Role: lead

Responsible Party

Abd-Elazeem Abd-Elhameed Elbakry

Assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Abd-Elazeem A Elbakry, M.D

Role: STUDY_CHAIR

Menoufia University

Locations

Faculty of Medicine

Cairo, Shebin El-kom, Egypt

Countries

Egypt

Other Identifiers

2017/3/1/4

Identifier Type: -

Identifier Source: org_study_id