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

NCT03622099 | Completed

• 1 other identifier: 2017/3/1/4
• Study Type: observational
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Circulatory Failure

Outcome Measures

Primary Outcomes (1)

• Aortic blood flow velocity Time Integral changes from the baseline

  \[cm\]

  Baseline 10 minutes before start of fluid challenge and1 minute after fluid challenge

Secondary Outcomes (10)

• stroke volume change from the baseline

  Baseline 10 minutes before start of fluid challenge and1 minute after fluid challenge

• cardiac output change from the baseline

  Baseline 10 minutes before start of fluid challenge and1 minute after fluid challenge

• heart rate change from the baseline

  Baseline 10 minutes before start of fluid challenge and1 minute after fluid challenge

• systolic blood pressure change from the baseline

  Baseline 10 minutes before start of fluid challenge and1 minute after fluid challenge

• Diastolic blood pressure change from the baseline

  Baseline 10 minutes before start of fluid challenge and1 minute after fluid challenge

Study Arms (1)

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.

Drug: Normal Saline Flush, 0.9% Injectable Solution

Interventions

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.

Also known as: normal saline

The study group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

in a general adult critical care unit (CCU) at Menoufia University Hospitals

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Menoufia University: lead

Study Sites (1)

Faculty of Medicine

Cairo, Shebin El-kom, 32511, Egypt

Location

MeSH Terms

Conditions

Shock

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Abd-Elazeem A Elbakry, M.D

  Menoufia University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: July 30, 2018
• First Posted: August 9, 2018
• Study Start: September 7, 2018
• Primary Completion: February 5, 2019
• Study Completion: February 26, 2019
• Last Updated: April 25, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: starting 6 months after publication
• Access Criteria: through the clinical trial registry site or contact by my e-mail

Locations

EG (1)