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Hemodynamic MonitoringNCT03893513

Comparison of Transthoracic Electrical Bioimpedance and Pulse Contour Analysis in Renal Transplantation Patients

An observational study of Hemodynamic Monitoring, run by Dita Aditianingsih at 1 site in Indonesia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Hemodynamics monitoring using non-invasive transthoracic electrical bioimpedance ICON are compatible with standard invasive monitoring using pulse contour analysis EV1000 Read more about this study

Who is it for?
Ages 18 to 80 yearsHealthy volunteers can take part
Conditions the study is for
Hemodynamic Monitoring
What is being tested?
Transthoracic Electrical Bioimpedance and Pulse Contour Analysis
Type of treatment
Medical device
How many people
50 participants
Where
1 siteIndonesia
Study dates
12 Mar 2019to 12 May 2019
Phase
Observational
Are there results?
None posted in the registry

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
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Patients planned to undergo elective kidney transplantation surgery as recipient

Who may be able to join

  • BMI 18.5 - 35 kg/m^2

Who cannot join

  • Heart function abnormalities (arrhythmia, AV block, using pacemaker, severe aorta stenosis)
  • Morbid obesity
  • Bradycardia (< 50 bpm)
  • Tachycardia (> 110 bpm)
  • refuse to participate

Trial locations and contacts

1 site in 1 country.

Indonesia1 site

  • Rumah Sakit Cipto Mangunkusumo

    Jakarta Pusat, DKI Jakarta, 10430

Other trials in Indonesia

About this study

Official title: Comparison of Transthoracic Electrical Bioimpedance and Pulse Contour Analysis in Renal Transplantation Patients: Analysis of Intraoperative Cardiac Output, Systemic Vascular Resistant and Stroke Volume Variation

Hemodynamics monitoring using non-invasive transthoracic electrical bioimpedance ICON are compatible with standard invasive monitoring using pulse contour analysis EV1000

Being tested
Transthoracic Electrical Bioimpedance, Pulse Contour Analysis
Keywords
Bio-impedance, Haemodynamic monitoring, Pulse contour analysis, kidney transplantation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Transthoracic Electrical BioimpedanceDevice

    Also called ICON

    Non-invasive hemodynamic monitor

  • Pulse Contour AnalysisDevice

    Also called EV1000

    Invasive hemodynamic monitor

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Hemodynamic correlation

    Correlation between hemodynamic measured between devices: cardiac index, stroke volume index, systemic vascular resistance index, stroke volume index

    Measured: Intraoperative

Secondary outcomes (4)

  1. Changes in hemodynamic profiles: Cardiac Index

    The trends of perioperative hemodynamic profiles during and after surgery: cardiac index in L/minutes/m^2

    Measured: Intraoperative

  2. Changes in hemodynamic profiles: Stroke Volume Index

    The trends of perioperative haemodynamic profiles during and after surgery: stroke volume index in mL/beat/m^2

    Measured: Intraoperative

  3. Changes in hemodynamic profiles: Systemic Vascular Resistance Index

    The trends of perioperative haemodynamic profiles during and after surgery: systemic vascular resistance index in dynes-second-m^2/cm^5

    Measured: Intraoperative

  4. Changes in hemodynamic profiles: Stroke Volume Variation

    The trends of perioperative haemodynamic profiles during and after surgery: stroke volume variation in %

    Measured: Intraoperative

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Mar 2019
  2. Study start12 Mar 2019
  3. Primary completion12 Apr 2019
  4. Study completion12 May 2019

Resources

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
Case only
Time perspective
Cross-sectional
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03893513
Sponsor's protocol ID
IndonesiaUAnes032
Status last verified
Jun 2019
First submitted
26 Mar 2019
Last updated
18 Jun 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes

Publications

  • Vincent JL, Pelosi P, Pearse R, Payen D, Perel A, Hoeft A, Romagnoli S, Ranieri VM, Ichai C, Forget P, Della Rocca G, Rhodes A. Perioperative cardiovascular monitoring of high-risk patients: a consensus of 12. Crit Care. 2015 May 8;19(1):224. doi: 10.1186/s13054-015-0932-7.

    PubMed 25953531

  • Joosten A, Huynh T, Suehiro K, Canales C, Cannesson M, Rinehart J. Goal-Directed fluid therapy with closed-loop assistance during moderate risk surgery using noninvasive cardiac output monitoring: A pilot study. Br J Anaesth. 2015 Jun;114(6):886-92. doi: 10.1093/bja/aev002. Epub 2015 Feb 17.

    PubMed 25690834

  • Pearse RM, Harrison DA, MacDonald N, Gillies MA, Blunt M, Ackland G, Grocott MP, Ahern A, Griggs K, Scott R, Hinds C, Rowan K; OPTIMISE Study Group. Effect of a perioperative, cardiac output-guided hemodynamic therapy algorithm on outcomes following major gastrointestinal surgery: a randomized clinical trial and systematic review. JAMA. 2014 Jun 4;311(21):2181-90. doi: 10.1001/jama.2014.5305.

    PubMed 24842135

  • Hamilton MA, Cecconi M, Rhodes A. A systematic review and meta-analysis on the use of preemptive hemodynamic intervention to improve postoperative outcomes in moderate and high-risk surgical patients. Anesth Analg. 2011 Jun;112(6):1392-402. doi: 10.1213/ANE.0b013e3181eeaae5. Epub 2010 Oct 21.

    PubMed 20966436

  • Sinclair S, James S, Singer M. Intraoperative intravascular volume optimisation and length of hospital stay after repair of proximal femoral fracture: randomised controlled trial. BMJ. 1997 Oct 11;315(7113):909-12. doi: 10.1136/bmj.315.7113.909.

    PubMed 9361539

  • Edison E, Pearse R. Goal directed therapy in the perioperative setting: What is the evidence? In: Paradise Lost and the Cosmological Revolution. 2014.

  • Aya HD, Cecconi M, Rhodes A. Perioperative Haemodynamic Optimisation. Turk J Anaesthesiol Reanim. 2014 Apr;42(2):56-65. doi: 10.5152/TJAR.2014.2220141. Epub 2014 Apr 1.

    PubMed 27366392

  • Saugel B, Cecconi M, Wagner JY, Reuter DA. Noninvasive continuous cardiac output monitoring in perioperative and intensive care medicine. Br J Anaesth. 2015 Apr;114(4):562-75. doi: 10.1093/bja/aeu447. Epub 2015 Jan 16.

    PubMed 25596280

  • Alhashemi JA, Cecconi M, Hofer CK. Cardiac output monitoring: an integrative perspective. Crit Care. 2011;15(2):214. doi: 10.1186/cc9996. Epub 2011 Mar 22. No abstract available.

    PubMed 21457508

  • Allaria B, Poli DM CD. Perioperative hemodynamic monitoring: invasive vs. non-invasive. In: Anesthesia, Pain, Intensive Care and Emergency Medicine - APICE. Italy: Springer-Verlag; 2013. p. 291-9.

  • Boyd O, Jackson N. How is risk defined in high-risk surgical patient management? Crit Care. 2005 Aug;9(4):390-6. doi: 10.1186/cc3057. Epub 2005 Feb 9.

    PubMed 16137389

  • Goldfarb D, Poggio E. Etiology, pathogenesis, and management of renal failure. In: Wein A, Kavoussi L, Novick A, Partin A, Peters C, editors. Campbell-Walsh Urology. 10th ed. Philadelphia: Elsevier Saunders; 2012. p. 1226-53.

  • Angelotti T, Lemmens H. Liver/Kidney/Pancreas transplantation. In: Jaffe R, Schmiesing C, Golianu B, editors. Anesthesiologist's Manual of Surgical Procedures. 5th editio. Philadelphia: Wolters Kluwer Health; 2014. p. 1097-100.

  • Darovic G. Hemodynamic monitoring: invasive and noninvasive clinical applications. 3rd ed. Darovic G, editor. Philadelphia: W.B. Saunders; 2002. 191-260 p.

  • Bendjelid K, Marx G, Kiefer N, Simon TP, Geisen M, Hoeft A, Siegenthaler N, Hofer CK. Performance of a new pulse contour method for continuous cardiac output monitoring: validation in critically ill patients. Br J Anaesth. 2013 Oct;111(4):573-9. doi: 10.1093/bja/aet116. Epub 2013 Apr 26.

    PubMed 23625132

Questions about this trial

What is this clinical trial studying?

An observational study of Hemodynamic Monitoring, run by Dita Aditianingsih at 1 site in Indonesia.

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 1 inclusion and 5 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: finished, as of the sponsor's last update on 18 Jun 2019. 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 Indonesia. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hemodynamic correlation (time frame: Intraoperative). 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 NCT03893513, which also lists 27 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 18 Jun 2019.

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