Hemodynamic InstabilityNCT05185141
Respiratory Variation of Carotid Doppler Peak Velocity (CDPV) for Non-invasive Prediction of Fluid Responsiveness
An observational study of Hemodynamic Instability, run by Johannes Gutenberg University Mainz at 1 site in Germany.
Trial summary
The purpose of this study is to assess respiratory variation of carotid doppler peak velocity (∆CDPV) for prediction of fluid responsiveness during major abdominal surgery. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hemodynamic Instability
- How many people
- 84 participants
- Where
- 1 siteGermany
- Study dates
- 11 Jan 2022to Jul 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Only patients scheduled for major abdominal surgery with an expected high intraoperative fluid turnover will be eligble for the study. Patients with any kind of crdiac arrhythmia, valve diseases, heart failure or carotid stenosis will be excluded from the study to avoid measurement errors and bias for the hemodynamic parameters such as pulse pressure variation, stroke volume and carotid doppler peak velocity.
Who may be able to join
- Age 18-80 years
- written informed consent
- scheduled major abdominal surgery
Who cannot join
- Age <18 or >80 years
- pregnancy
- SIRS or sepsis
- any kind of cardiac arrhythmia
- known valve disease
- known heart failure
Show all 16Show fewer
- any kind of known carotid stenosis
- carotid doppler peak velocity >182 cm/s before baseline measurement (expected stenosis)
- missing indication for invasive arterial blood pressure monitoring (IBP) not related to the study
- peripheral artery disease (PAD)
- BMI > 35 kg/m2
- intraabdominal hypertension
- ASA-PSC of 4
- severe lung disease (e.g. COPD grade 3, fibrosis)
- esophageal disease of any kind
- participation in another clinical study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Department of Anesthesiology, Johannes-Gutenberg University Medical Center
Mainz, Rhineland-Palatinate, 55131
Johannes M Wirkus, M.D., +49 6131 17-0, johannes.wirkus@unimedizin-mainz.de
About this study
Official title: Assessing Respiratory Variation of Carotid Doppler Peak Velocity (CDPV) for Non-invasive Prediction of Fluid Responsiveness During Abdominal Surgery: a Prospective Observational Trial
The purpose of this study is to assess respiratory variation of carotid doppler peak velocity (∆CDPV) for prediction of fluid responsiveness during major abdominal surgery.
Read the detailed description
Investigating hemodynamic parameters in a group of 19 ICU-patients with septic shock, respiratory variation of carotid doppler peak velocity (∆CDPV) has been shown to be able to predict fluid responsiveness. For patients receiving so called lung protective ventilation with a tidal volume of 6ml/kg ∆CDPV was superior for prediction of fluid responsiveness when compared to other well established parameters such as pulse pressure variation (∆PP).
Likewise in another study ∆CDPV has been shown to be superior to stroke volume variation (∆SV) for prediction of fluid responsiveness in patients with septic shock when ventilated with a tidal volume of ≥8ml/ kg.
All in all respiratory variation of carotid doppler peak velocity (∆CDPV) seems to be a promising parameter for prediction of fluid responsiveness (Yao et al., BMC Anesthesiology 2018). However, so far clinical studies have been conducted only under a small number of patients mainly in the intensive care unit and/ or under highly specific conditions (e.g. cardiac surgery).
If ∆CDPV is able to predict fluid responsiveness with high accuracy intraoperatively remains unknown. The investigators are therefore conducting this prospective monocentric observational trial to evaluate the performance of ∆CDPV during major abdominal surgery and compare it to validated fluid responsiveness monitoring parameters ∆PP and corrected flow time (fTc).
Following IRB-approval and written informed consent 84 patients scheduled for major abdominal surgery will be enrolled in the study. Stroke volume will be monitored by Esophageal Doppler Monitoring (CardioQ-ODM®, Deltex Medical Ltd, Chichester, UK). In case of hypovolemia a fluid bolus of 7 ml/kg ideal body weight will be administered at the discretion of the attending anesthesiologist. Respiratory variation of carotid doppler peak velocity (∆CDPV) will be monitored before and 1 minute after completion of each fluid bolus using an ultrasound device with a common linear array transducer (Philips ClearVue 350, Philips Medizin Systeme GmbH, Boeblingen, Germany).
- Conditions
- Hemodynamic Instability
- Keywords
- Fluid Responsiveness, Hemodynamic Monitoring, Carotid Doppler Peak Velocity, Pulse Pressure Variation, Fluid Challenge
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in stroke volume following a fluid bolus.
A rise in stroke volume of ≥10% following a fluid bolus of 7ml/kg Ideal Body Weight is considered to reflect fluid responsiveness. Measurements will be assessed through esophageal doppler monitoring.
Measured: Immediately before and 1 minute after completion of each fluid bolus.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2022
- Study start11 Jan 2022
- Primary completionJul 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Hemodynamic InstabilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johannes Gutenberg University Mainz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Johannes M Wirkus, MD, Johannes Gutenberg University Mainz
- Investigators
- Gunther J Pestel, M.D., Ph.D., Study chair, Johannes Gutenberg University Medical Center, Dpt. of AnesthesiologyKimiko Fukui-Dunkel, M.D., Ph.D., Study director, Johannes Gutenberg University Medical Center, Dpt. of Anesthesiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05185141
- Sponsor's protocol ID
- 21-02546
- Status last verified
- Jun 2026
- First submitted
- 20 Dec 2021
- Last updated
- 10 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ibarra-Estrada MA, Lopez-Pulgarin JA, Mijangos-Mendez JC, Diaz-Gomez JL, Aguirre-Avalos G. Respiratory variation in carotid peak systolic velocity predicts volume responsiveness in mechanically ventilated patients with septic shock: a prospective cohort study. Crit Ultrasound J. 2015 Dec;7(1):29. doi: 10.1186/s13089-015-0029-1. Epub 2015 Jun 26.
PubMed 26123610Lu N, Xi X, Jiang L, Yang D, Yin K. Exploring the best predictors of fluid responsiveness in patients with septic shock. Am J Emerg Med. 2017 Sep;35(9):1258-1261. doi: 10.1016/j.ajem.2017.03.052. Epub 2017 Mar 22.
PubMed 28363617Yao B, Liu JY, Sun YB. Respiratory variation in peripheral arterial blood flow peak velocity to predict fluid responsiveness in mechanically ventilated patients: a systematic review and meta-analysis. BMC Anesthesiol. 2018 Nov 13;18(1):168. doi: 10.1186/s12871-018-0635-0.
PubMed 30424730
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Respiratory Variation of Carotid Doppler Peak Velocity (CDPV) for Non-invasive Prediction of Fluid Responsiveness During Abdominal Surgery: a Prospective Observational Trial
- ClinicalTrials.gov ID
- NCT05185141
- Acronym / sponsor ID
- 21-02546
- Conditions
- Hemodynamic Instability
- Keywords
- Fluid Responsiveness, Hemodynamic Monitoring, Carotid Doppler Peak Velocity, Pulse Pressure Variation, Fluid Challenge
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Johannes Gutenberg University MainzUniversity, hospital or other
- Study start
- 11 Jan 2022 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 11 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess respiratory variation of carotid doppler peak velocity (∆CDPV) for prediction of fluid responsiveness during major abdominal surgery.
Detailed description
Investigating hemodynamic parameters in a group of 19 ICU-patients with septic shock, respiratory variation of carotid doppler peak velocity (∆CDPV) has been shown to be able to predict fluid responsiveness. For patients receiving so called lung protective ventilation with a tidal volume of 6ml/kg ∆CDPV was superior for prediction of fluid responsiveness when compared to other well established parameters such as pulse pressure variation (∆PP).
Likewise in another study ∆CDPV has been shown to be superior to stroke volume variation (∆SV) for prediction of fluid responsiveness in patients with septic shock when ventilated with a tidal volume of ≥8ml/ kg.
All in all respiratory variation of carotid doppler peak velocity (∆CDPV) seems to be a promising parameter for prediction of fluid responsiveness (Yao et al., BMC Anesthesiology 2018). However, so far clinical studies have been conducted only under a small number of patients mainly in the intensive care unit and/ or under highly specific conditions (e.g. cardiac surgery).
If ∆CDPV is able to predict fluid responsiveness with high accuracy intraoperatively remains unknown. The investigators are therefore conducting this prospective monocentric observational trial to evaluate the performance of ∆CDPV during major abdominal surgery and compare it to validated fluid responsiveness monitoring parameters ∆PP and corrected flow time (fTc).
Following IRB-approval and written informed consent 84 patients scheduled for major abdominal surgery will be enrolled in the study. Stroke volume will be monitored by Esophageal Doppler Monitoring (CardioQ-ODM®, Deltex Medical Ltd, Chichester, UK). In case of hypovolemia a fluid bolus of 7 ml/kg ideal body weight will be administered at the discretion of the attending anesthesiologist. Respiratory variation of carotid doppler peak velocity (∆CDPV) will be monitored before and 1 minute after completion of each fluid bolus using an ultrasound device with a common linear array transducer (Philips ClearVue 350, Philips Medizin Systeme GmbH, Boeblingen, Germany).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Only patients scheduled for major abdominal surgery with an expected high intraoperative fluid turnover will be eligble for the study. Patients with any kind of crdiac arrhythmia, valve diseases, heart failure or carotid stenosis will be excluded from the study to avoid measurement errors and bias for the hemodynamic parameters such as pulse pressure variation, stroke volume and carotid doppler peak velocity.
Key inclusion criteria (3 listed)
- Age 18-80 years
- written informed consent
- scheduled major abdominal surgery
Key exclusion criteria (16 listed)
- Age <18 or >80 years
- pregnancy
- SIRS or sepsis
- any kind of cardiac arrhythmia
- known valve disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in stroke volume following a fluid bolus.
Time frame: Immediately before and 1 minute after completion of each fluid bolus.
A rise in stroke volume of ≥10% following a fluid bolus of 7ml/kg Ideal Body Weight is considered to reflect fluid responsiveness. Measurements will be assessed through esophageal doppler monitoring.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2026.
- Background: PubMed 26123610Ibarra-Estrada MA, Lopez-Pulgarin JA, Mijangos-Mendez JC, Diaz-Gomez JL, Aguirre-Avalos G. Respiratory variation in carotid peak systolic velocity predicts volume responsiveness in mechanically ventilated patients with septic shock: a prospective cohort study. Crit Ultrasound J. 2015 Dec;7(1):29. doi: 10.1186/s13089-015-0029-1. Epub 2015 Jun 26.
- Background: PubMed 28363617Lu N, Xi X, Jiang L, Yang D, Yin K. Exploring the best predictors of fluid responsiveness in patients with septic shock. Am J Emerg Med. 2017 Sep;35(9):1258-1261. doi: 10.1016/j.ajem.2017.03.052. Epub 2017 Mar 22.
- Background: PubMed 30424730Yao B, Liu JY, Sun YB. Respiratory variation in peripheral arterial blood flow peak velocity to predict fluid responsiveness in mechanically ventilated patients: a systematic review and meta-analysis. BMC Anesthesiol. 2018 Nov 13;18(1):168. doi: 10.1186/s12871-018-0635-0.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gunther J Pestel, M.D., Ph.D. study chair
Johannes Gutenberg University Medical Center, Dpt. of Anesthesiology
Kimiko Fukui-Dunkel, M.D., Ph.D. study director
Johannes Gutenberg University Medical Center, Dpt. of Anesthesiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hemodynamic Instability, run by Johannes Gutenberg University Mainz at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Johannes M Wirkus, M.D. (+49 6131 17- 7175, johannes.wirkus@unimedizin-mainz.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in stroke volume following a fluid bolus. (time frame: Immediately before and 1 minute after completion of each fluid bolus.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05185141, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2026.