Fluid Responseveness in Sepsis and Its Correlation to CVP

NCT ID: NCT05612529

Last Updated: 2023-01-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

45 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-04-01

Study Completion Date

2022-11-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Septic Shock

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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US , Echocardiography

* Carotid ultrasonography: Parameters will be measured by single blinded independent examiner using an ultrasound device. Baseline carotid FTc, ΔVpeak, will be measured.
* Echocardiography: Stroke Volume will be measured by transthoracic echocardiography.
* Renal and splenic Doppler resistivity index.
* Inferior vena cava collapsibility and distensibility indices.
* Central venous pressure estimation by central venous catheter, and central - Lung ultrasound for detection of lung congestion
* Lung ultrasound for detection of lung congestion.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Tasneem Hassan Younes

Assistant lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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olfat M elshinawy, professor

Role: PRINCIPAL_INVESTIGATOR

Assiut University

mohamed M abdelhady, professor

Role: PRINCIPAL_INVESTIGATOR

Assiut University

arafa M aboelhassan

Role: PRINCIPAL_INVESTIGATOR

Assiut University

Locations

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Tasneem Hassan Younes

Asyut, , Egypt

Site Status

Countries

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Egypt

References

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Levy MM, Evans LE, Rhodes A. The Surviving Sepsis Campaign Bundle: 2018 update. Intensive Care Med. 2018 Jun;44(6):925-928. doi: 10.1007/s00134-018-5085-0. Epub 2018 Apr 19. No abstract available.

Reference Type BACKGROUND
PMID: 29675566 (View on PubMed)

Vandervelden S, Malbrain ML. Initial resuscitation from severe sepsis: one size does not fit all. Anaesthesiol Intensive Ther. 2015;47 Spec No:s44-55. doi: 10.5603/AIT.a2015.0075. Epub 2015 Nov 18.

Reference Type BACKGROUND
PMID: 26578400 (View on PubMed)

Lammi MR, Aiello B, Burg GT, Rehman T, Douglas IS, Wheeler AP, deBoisblanc BP; National Institutes of Health, National Heart, Lung, and Blood Institute ARDS Network Investigators. Response to fluid boluses in the fluid and catheter treatment trial. Chest. 2015 Oct;148(4):919-926. doi: 10.1378/chest.15-0445.

Reference Type BACKGROUND
PMID: 26020673 (View on PubMed)

Hu B, Xiang H, Liang H, Yu L, Xu T, Yang JH, DU ZH, Li JG. Assessment effect of central venous pressure in fluid resuscitation in the patients with shock: a multi-center retrospective research. Chin Med J (Engl). 2013;126(10):1844-9.

Reference Type BACKGROUND
PMID: 23673097 (View on PubMed)

Corradi F, Via G, Tavazzi G. What's new in ultrasound-based assessment of organ perfusion in the critically ill: expanding the bedside clinical monitoring window for hypoperfusion in shock. Intensive Care Med. 2020 Apr;46(4):775-779. doi: 10.1007/s00134-019-05791-y. Epub 2019 Oct 25. No abstract available.

Reference Type BACKGROUND
PMID: 31654077 (View on PubMed)

Kim HJ, Choi YS, Kim SH, Lee W, Kwon JY, Kim DH. Predictability of preoperative carotid artery-corrected flow time for hypotension after spinal anaesthesia in patients undergoing caesarean section: A prospective observational study. Eur J Anaesthesiol. 2021 Apr 1;38(4):394-401. doi: 10.1097/EJA.0000000000001376.

Reference Type BACKGROUND
PMID: 33122575 (View on PubMed)

Other Identifiers

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fluid responseveness in sepsis

Identifier Type: -

Identifier Source: org_study_id

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