Fluid Responseveness in Sepsis and Its Correlation to CVP

January 26, 2023 updated by: Tasneem Hassan Younes, Assiut University

Ultrasonographic Predictors of Intravenous Fluid Responsiveness in Septic Shock and Its Correlation to Central Venous Pressure

Introduction Aim of the work Patients and methods Type of study Exclusion criteria Statistical analysis Research ethics Reference

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Septic shock is a serious infectious condition characterized by low blood pressure and multiple organ damage. One of the traditional recommendations is to administer intravenous fluids as the first step to improve blood pressure(1).

However, studies have shown that not every patient benefits from aggressive intravenous hydration (2).

Previous studies have shown that certain parameters may correlate with volume status and others may not to correlate with patient volume status.

Hemodynamic parameters, such as stroke volume variation (SVV) and pleth variability index (PVI) may better predict fluid responsiveness. However, assessments of these parameters require invasive procedures and special monitoring equipment, which limits their clinical application (4).

Echocardiography has been widely adopted to diagnose and monitor cardiac dysfunction leading to hemodynamic instability, and shock pathophysiology in general.

However, the echocardiographic information on macro-hemodynamics is partial, especially as being indirect as concerns vascular tone, and not allowing any inference on end-organ perfusion (5).

Recently, ultrasonography for estimating volume status has been widely recommended because of its non-invasive nature, ease of acquisition, and reproducibility of measurements.

The inferior vena cava (IVC) is a compliant vessel whose size and shape vary with changes in CVP and intravascular volume. Therefore, sonographic measurement of the IVC represents an effective and non-invasive method of estimating CVP.

Respiratory variation in the IVC diameter was used as a guide for fluid therapy in septic shock in both spontaneous breathing and mechanically ventilated patients.

Moreover, the assessment of visceral end-organ perfusion by ultrasound, may offer insights into this facet of shock pathophysiology (5).

Among these ultrasound modalities, corrected flow time (FTc) measured in the carotid artery is a new approach for predicting fluid responsiveness that has shown promising results.

Therefore, although it is a dynamic index, it may be able to adequately evaluate volume status in spontaneously and mechanically breathing patients.

Aim of the work: 1- To evaluate whether carotid FTc as determined by Doppler ultrasound could be a predictor of fluid responsiveness in spontaneously breathing and mechanically ventilated patients.

2- To evaluate the predictive ability of ΔVpeak for fluid responsiveness in spontaneously breathing patients.

3- To detect changes of regional splanchnic hemodynamics by color Doppler resistive index, and its improvement after fluid administration.

4- To evaluate the predictive ability of IVC collapsibility and distensibility indices for fluid responsiveness in septic shock patients.

5- To compare between the predictive ability of the measured Ultrasonographic parameters and the CVP changes in response to intravenous fluid therapy in both spontaneously breathing and mechanically ventilated septic shock patients.

Study Type

Observational

Enrollment (Actual)

45

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
      • Assiut, Egypt
        • Tasneem Hassan Younes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

After recording these data, the patients will be administered a fluid challenge of a 500 mL fluid bolus of 0.9% normal saline over 10 min and then same haemodynamic parameters will be measured again.

Fluid responsiveness is an increase of stroke volume of 10-15% by echocardiography, after the patient receives 500 ml of crystalloid over 10 min.

Description

Inclusion Criteria:

  1. adult patients age≥18-year-old; written consent will be obtained.
  2. septic shocked patients show signs of acute circulatory failure at any time within the first 72 hours.

Exclusion Criteria:

  1. Patients confirmed to have cardiogenic shock.
  2. History of heart failure or patient known to have moderate to severe valvular heart disease, congenital heart disease.
  3. The presence of carotid artery stenosis >50% , newly detected common carotid stenosis >50% during the study period.
  4. Non-sinus rhythm.
  5. Moderate to severe anemia.
  6. Markedly increased intraabdominal pressure as abdominal compartment syndrome, pregnancy.
  7. Medically diseased kidneys, ureteric obstruction peri-nephric collection.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ultrasonographic predictors of intravenous fluid responsiveness in septic shock and its correlation to central venous pressure
Time Frame: Baseline
To evaluate whether carotid FTc as determined by Doppler ultrasound could be a predictor of fluid responsiveness in spontaneously breathing and MV patients.
Baseline
Evaluation the predictive ability of ΔVpeak for fluid responsiveness in spontaneously breathing patients.
Time Frame: Baseline

To evaluate the predictive ability of ΔVpeak for fluid responsiveness in spontaneously breathing patients.

and the ΔVpeak will be calculated as follows: (maximum peak velocity - minimum peak velocity)/[(maximum peak velocity + minimum peak velocity)/2] × 100
Baseline
Detection changes of regional splanchnic hemodynamics by color Doppler resistive index, and its improvement after fluid administration.
Time Frame: Baseline

To detect changes of regional splanchnic hemodynamics by color Doppler resistive index, and its improvement after fluid administration.

Resistive index (RI): (peak systolic velocity - end-diastolic velocity) / peak systolic velocity. The normal range is 0.50-0.70.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Principal Investigator: olfat M elshinawy, professor, Assiut University
  • Principal Investigator: mohamed M abdelhady, professor, Assiut University
  • Principal Investigator: arafa M aboelhassan, Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2022

Primary Completion (Actual)

November 30, 2022

Study Completion (Actual)

November 30, 2022

Study Registration Dates

First Submitted

October 27, 2021

First Submitted That Met QC Criteria

November 8, 2022

First Posted (Actual)

November 10, 2022

Study Record Updates

Last Update Posted (Estimate)

January 30, 2023

Last Update Submitted That Met QC Criteria

January 26, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • fluid responseveness in sepsis

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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