Fluid Responseveness in Sepsis and Its Correlation to CVP

NCT05612529 | Terminated

• 1 other identifier: fluid responseveness in sepsis
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Septic Shock

Outcome Measures

Primary Outcomes (3)

• Ultrasonographic predictors of intravenous fluid responsiveness in septic shock and its correlation to central venous pressure

  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.

  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.

  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

Interventions

US , Echocardiography DEVICE

* 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.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Tasneem Hassan Younes

Asyut, Egypt

Location

Related Publications (6)

• 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.

  PMID: 29675566 BACKGROUND

• 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.

  PMID: 26578400 BACKGROUND

• 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.

  PMID: 26020673 BACKGROUND

• 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.

  PMID: 23673097 BACKGROUND

• 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.

  PMID: 31654077 BACKGROUND

• 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.

  PMID: 33122575 BACKGROUND

MeSH Terms

Conditions

Shock, Septic

Interventions

Echocardiography

Condition Hierarchy (Ancestors)

Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Intervention Hierarchy (Ancestors)

Cardiac Imaging Techniques; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Ultrasonography; Heart Function Tests; Diagnostic Techniques, Cardiovascular

Study Officials

• olfat M elshinawy, professor

  Assiut University

  PRINCIPAL INVESTIGATOR

• mohamed M abdelhady, professor

  Assiut University

  PRINCIPAL INVESTIGATOR

• arafa M aboelhassan

  Assiut University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer

Study Record Dates

• First Submitted: October 27, 2021
• First Posted: November 10, 2022
• Study Start: April 1, 2022
• Primary Completion: November 30, 2022
• Study Completion: November 30, 2022
• Last Updated: January 30, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)