Cardiac Output, HighNCT02060942

Mean Systemic Filling Pressure and Heart Performance Predicting Fluid Responsiveness

An observational study of Cardiac Output, High, run by Catharina Ziekenhuis Eindhoven at 1 site in Netherlands.

Completed

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

Trial summary

Determining fluid responsiveness in critically ill patients by measuring mean systemic filling pressure on the intensive care unit. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Cardiac Output, High
How many people: 40 participants
Where: 1 siteNetherlands
Study dates: Aug 2013to Jan 2015
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: Coronary artery bypass grafting, aortic valve replacement and septic shock patients

Who may be able to join

Patients must be older than 18 years, and must be equipped with a pulse-contour cardiac output system with a central venous catheter. Patients will be subsequently connected to the hemodynamic monitoring device Navigator™. In those patients with clinical signs of inadequate tissue perfusion, passive leg raising and standardized fluid challenge will be performed.

Who cannot join

Patients with assist devices (e.g. intra aortic balloon pump, Impella®, ECMO), patients with arrhythmias (either atrial of ventricular) will be excluded from the study. Also, patients with inguinal impairment or contraindications for a passive leg raising will be excluded (such as deep venous thrombosis or elastic compression stocking), head trauma, an increase intra-abdominal pressure suspected by clinical context and examination as well as patients with absolute contraindications for fluid challenge.

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

Catharina Hospital
Eindhoven, North Brabant, 5623 EJ

Other trials in Netherlands

About this study

Official title: Mean Systemic Filling Pressure and Heart Performance as Predictors of Successful Fluid Responsiveness in Patients With Coronary Artery Bypass Grafting

Determining fluid responsiveness in critically ill patients by measuring mean systemic filling pressure on the intensive care unit.

Read the detailed description

The assessment of the cardiovascular state in critically ill patients is subject to difficulties in terms of the fact that several hemodynamic parameters, for example mean arterial blood pressure (MAP) and cardiac output (CO) supply insufficient information about the circulating volume and cardiac performance. There is a clinical need to adequate determination of intravascular volume status and therefore reliable predictors of fluid responsiveness are highly relevant. However, in determining the fluid status of a patient, the lack of appreciation of the venous side of the circulation persists today, which is greatly due to the inability to appropriately assess the venous side of the circulation. The importance of the venous part of the circulation is moreover reflected by the fact that an increase in venous resistance does reduce CO many times more than a similar increase in arterial resistance. Mean systemic filling pressure (Pms), which is defined as the pressure equal to the pressure which would be measured if the heart should suddenly stop pumping and all (arterial and venous) the pressures in the entire circulatory system should be brought to equilibrium instantaneously, is a good, complete and reliable reflection of the total intravascular fluid compartment. Passive leg raising (PLR) represents a "self-volume challenge" that predicts preload responsiveness and the transient hemodynamic changes on venous return can be directly monitored in ventilated patients, provided that there is an intact circulation, in order to test the amount of volume responsiveness.

Conditions: Cardiac Output, High
Keywords: Volume responsiveness mean systemic filling pressure
Medical subject headings: Cardiac Output, High

What participants receive

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

Study groups in NCT02060942
Study group	Role	What they receive
Coronary artery bypass grafting		Post Anaesthetic Care Unit (PACU) patients treated with coronary artery bypass grafting (CABG) are highly eligible for this study. These are patients with an indication for fast track treatment (PACU) post-cardiac surgery with a good left ventricular ejection fraction without significant co-morbidity. The final decision for PACU-classification is taken by the responsible anaesthesiologist and intensivist in close collaboration with the cardiothoracic surgeon performing the operation, as well as the cardiologist.

What is being measured

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

Mean systemic filling pressure (Pms)
An increase in mean systemic filling pressure after (self)volume-challenge indicating volume responsiveness of the patient
Measured: 1 hour

Secondary outcomes (1)

Heart performance (eH)
Quotient of driving pressure of venous return in mmHg
Measured: 1 hour

Timeline

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

Aug 2013Jan 2015

First posted12 Feb 2014 (estimated)
Study startAug 2013
Primary completionJan 2015
Study completionJan 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (21)Papers the sponsor has linked to this study.
Other trials for Cardiac Output, HighStudies 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: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02060942
Sponsor's protocol ID: M12-1271
Status last verified: May 2016
First submitted: 23 Aug 2013
Last updated: 19 May 2016
Results posted: No
Data monitoring committee: No
Individual data sharing: No: No, data remain anonymized within hospital and property of PI.

Publications

Parkin WG, Leaning MS. Therapeutic control of the circulation. J Clin Monit Comput. 2008 Dec;22(6):391-400. doi: 10.1007/s10877-008-9147-7. Epub 2008 Nov 12.
PubMed 19002596
Lansdorp B, Lemson J, van Putten MJ, de Keijzer A, van der Hoeven JG, Pickkers P. Dynamic indices do not predict volume responsiveness in routine clinical practice. Br J Anaesth. 2012 Mar;108(3):395-401. doi: 10.1093/bja/aer411. Epub 2011 Dec 20.
PubMed 22185905
Michard F, Teboul JL. Predicting fluid responsiveness in ICU patients: a critical analysis of the evidence. Chest. 2002 Jun;121(6):2000-8. doi: 10.1378/chest.121.6.2000.
PubMed 12065368
Monnet X, Rienzo M, Osman D, Anguel N, Richard C, Pinsky MR, Teboul JL. Passive leg raising predicts fluid responsiveness in the critically ill. Crit Care Med. 2006 May;34(5):1402-7. doi: 10.1097/01.CCM.0000215453.11735.06.
PubMed 16540963
Keller G, Desebbe O, Benard M, Bouchet JB, Lehot JJ. Bedside assessment of passive leg raising effects on venous return. J Clin Monit Comput. 2011 Aug;25(4):257-63. doi: 10.1007/s10877-011-9303-3. Epub 2011 Sep 24.
PubMed 21948105
Maas JJ, Geerts BF, van den Berg PC, Pinsky MR, Jansen JR. Assessment of venous return curve and mean systemic filling pressure in postoperative cardiac surgery patients. Crit Care Med. 2009 Mar;37(3):912-8. doi: 10.1097/CCM.0b013e3181961481.
PubMed 19237896
Anderson RM, Fritz JM, O'Hare JE. The mechanical nature of the heart as a pump. Am Heart J. 1967 Jan;73(1):92-105. doi: 10.1016/0002-8703(67)90313-4. No abstract available.
PubMed 6016029
Rothe CF. Mean circulatory filling pressure: its meaning and measurement. J Appl Physiol (1985). 1993 Feb;74(2):499-509. doi: 10.1152/jappl.1993.74.2.499.
PubMed 8458763
GUYTON AC, ABERNATHY B, LANGSTON JB, KAUFMANN BN, FAIRCHILD HM. Relative importance of venous and arterial resistances in controlling venous return and cardiac output. Am J Physiol. 1959 May;196(5):1008-14. doi: 10.1152/ajplegacy.1959.196.5.1008. No abstract available.
PubMed 13649920
GUYTON AC, POLIZO D, ARMSTRONG GG. Mean circulatory filling pressure measured immediately after cessation of heart pumping. Am J Physiol. 1954 Nov;179(2):261-7. doi: 10.1152/ajplegacy.1954.179.2.261. No abstract available.
PubMed 13218155
GUYTON AC, LINDSEY AW, KAUFMANN BN. Effect of mean circulatory filling pressure and other peripheral circulatory factors on cardiac output. Am J Physiol. 1955 Mar;180(3):463-8. doi: 10.1152/ajplegacy.1955.180.3.463. No abstract available.
PubMed 14376522
GUYTON AC, LINDSEY AW, ABERNATHY B, RICHARDSON T. Venous return at various right atrial pressures and the normal venous return curve. Am J Physiol. 1957 Jun;189(3):609-15. doi: 10.1152/ajplegacy.1957.189.3.609. No abstract available.
PubMed 13458395
Parkin WG. Volume state control - a new approach. Crit Care Resusc. 1999 Sep;1(3):311-21.
PubMed 16603021
Pellegrino VA, Mudaliar Y, Gopalakrishnan M, Horton MD, Killick CJ, Parkin WG, Playford HR, Raper RF. Computer based haemodynamic guidance system is effective and safe in management of postoperative cardiac surgery patients. Anaesth Intensive Care. 2011 Mar;39(2):191-201. doi: 10.1177/0310057X1103900207.
PubMed 21485666
Jansen JR, Maas JJ, Pinsky MR. Bedside assessment of mean systemic filling pressure. Curr Opin Crit Care. 2010 Jun;16(3):231-6. doi: 10.1097/MCC.0b013e3283378185.
PubMed 20168223

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Efficacy and Tolerance of Treatment With Bevacizumab for Severe Liver Involvement With High Cardiac Output in Hereditary Hemorrhagic Telangiectasia Within the French Hereditary Hemorrhagic Telangiectasia Network
Hereditary Hemorrhagic Telangiectasia (HHT), Pulmonary Hypertension
RecruitingObservational study
The HIgh-fidelity Hydraulic couPling Upper-arm Cuff Assessment of Limits, Safety, and Effectiveness (HIPULSE) Trial (Cardiac Output Study)
ICU, Pulmonary Artery Catheter (PAC)
Recruiting
Intraoperative Multimodal Monitoring as a Means in Reducing the Duration of Mechanical Ventilation in High-Risk Patients Undergoing Major Abdominal Procedures - A Pilot Study
Major Abdominal Surgeries, Mechanical Ventilation
RecruitingObservational study
Effect of Labetalol, Atenolol, and Nifedipine on Maternal Hemodynamics Measured by ICG in Early Pregnancy
Systolic Hypertension, Pregnancy Related
Recruiting
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All Cardiac Output, High trials

Study at a glance

From the registry record, last updated by the sponsor on 19 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Mean Systemic Filling Pressure and Heart Performance as Predictors of Successful Fluid Responsiveness in Patients With Coronary Artery Bypass Grafting
ClinicalTrials.gov ID: NCT02060942
Acronym / sponsor ID: M12-1271
Conditions: Cardiac Output, High
Keywords: Volume responsiveness mean systemic filling pressure
Study type: Observational
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: Catharina Ziekenhuis EindhovenUniversity, hospital or other
Collaborators: Erasmus Medical Center
Study start: Aug 2013
Primary completion: Jan 2015 (actual)
Study completion: Jan 2015 (actual)
First posted: 12 Feb 2014 (estimated)
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.

Determining fluid responsiveness in critically ill patients by measuring mean systemic filling pressure on the intensive care unit.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Coronary artery bypass grafting	–	–Post Anaesthetic Care Unit (PACU) patients treated with coronary artery bypass grafting (CABG) are highly eligible for this study. These are patients with an indication for fast track treatment (PACU) post-cardiac surgery with a good left ventricular ejection fraction without significant co-morbidity. The final decision for PACU-classification is taken by the responsible anaesthesiologist and intensivist in close collaboration with the cardiothoracic surgeon performing the operation, as well as the cardiologist.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Coronary artery bypass grafting, aortic valve replacement and septic shock patients

Key inclusion criteria (1 listed)

Patients must be older than 18 years, and must be equipped with a pulse-contour cardiac output system with a central venous catheter. Patients will be subsequently connected to the hemodynamic monitoring device Navigator™. In those patients with clinical signs of inadequate tissue perfusion, passive leg raising and standardized fluid challenge will be performed.

Key exclusion criteria (1 listed)

Patients with assist devices (e.g. intra aortic balloon pump, Impella®, ECMO), patients with arrhythmias (either atrial of ventricular) will be excluded from the study. Also, patients with inguinal impairment or contraindications for a passive leg raising will be excluded (such as deep venous thrombosis or elastic compression stocking), head trauma, an increase intra-abdominal pressure suspected by clinical context and examination as well as patients with absolute contraindications for fluid challenge.

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

Mean systemic filling pressure (Pms)
Time frame: 1 hour
An increase in mean systemic filling pressure after (self)volume-challenge indicating volume responsiveness of the patient

1 secondary outcome

Heart performance (eH)
Time frame: 1 hour

Results and safety

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

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2016.
Background: PubMed 19002596Parkin WG, Leaning MS. Therapeutic control of the circulation. J Clin Monit Comput. 2008 Dec;22(6):391-400. doi: 10.1007/s10877-008-9147-7. Epub 2008 Nov 12.
Background: PubMed 22185905Lansdorp B, Lemson J, van Putten MJ, de Keijzer A, van der Hoeven JG, Pickkers P. Dynamic indices do not predict volume responsiveness in routine clinical practice. Br J Anaesth. 2012 Mar;108(3):395-401. doi: 10.1093/bja/aer411. Epub 2011 Dec 20.
Background: PubMed 12065368Michard F, Teboul JL. Predicting fluid responsiveness in ICU patients: a critical analysis of the evidence. Chest. 2002 Jun;121(6):2000-8. doi: 10.1378/chest.121.6.2000.
Background: PubMed 16540963Monnet X, Rienzo M, Osman D, Anguel N, Richard C, Pinsky MR, Teboul JL. Passive leg raising predicts fluid responsiveness in the critically ill. Crit Care Med. 2006 May;34(5):1402-7. doi: 10.1097/01.CCM.0000215453.11735.06.
Background: PubMed 21948105Keller G, Desebbe O, Benard M, Bouchet JB, Lehot JJ. Bedside assessment of passive leg raising effects on venous return. J Clin Monit Comput. 2011 Aug;25(4):257-63. doi: 10.1007/s10877-011-9303-3. Epub 2011 Sep 24.
Background: PubMed 19237896Maas JJ, Geerts BF, van den Berg PC, Pinsky MR, Jansen JR. Assessment of venous return curve and mean systemic filling pressure in postoperative cardiac surgery patients. Crit Care Med. 2009 Mar;37(3):912-8. doi: 10.1097/CCM.0b013e3181961481.
Background: PubMed 6016029Anderson RM, Fritz JM, O'Hare JE. The mechanical nature of the heart as a pump. Am Heart J. 1967 Jan;73(1):92-105. doi: 10.1016/0002-8703(67)90313-4. No abstract available.
Background: PubMed 8458763Rothe CF. Mean circulatory filling pressure: its meaning and measurement. J Appl Physiol (1985). 1993 Feb;74(2):499-509. doi: 10.1152/jappl.1993.74.2.499.
Background: PubMed 13649920GUYTON AC, ABERNATHY B, LANGSTON JB, KAUFMANN BN, FAIRCHILD HM. Relative importance of venous and arterial resistances in controlling venous return and cardiac output. Am J Physiol. 1959 May;196(5):1008-14. doi: 10.1152/ajplegacy.1959.196.5.1008. No abstract available.
Background: PubMed 13218155GUYTON AC, POLIZO D, ARMSTRONG GG. Mean circulatory filling pressure measured immediately after cessation of heart pumping. Am J Physiol. 1954 Nov;179(2):261-7. doi: 10.1152/ajplegacy.1954.179.2.261. No abstract available.
Background: PubMed 14376522GUYTON AC, LINDSEY AW, KAUFMANN BN. Effect of mean circulatory filling pressure and other peripheral circulatory factors on cardiac output. Am J Physiol. 1955 Mar;180(3):463-8. doi: 10.1152/ajplegacy.1955.180.3.463. No abstract available.
Background: PubMed 13458395GUYTON AC, LINDSEY AW, ABERNATHY B, RICHARDSON T. Venous return at various right atrial pressures and the normal venous return curve. Am J Physiol. 1957 Jun;189(3):609-15. doi: 10.1152/ajplegacy.1957.189.3.609. No abstract available.
Individual participant dataSharing planned: No. No, data remain anonymized within hospital and property of PI.

Related trials for Cardiac Output, High

Enrolling by invitationObservational study
Efficacy and Tolerance of Treatment With Bevacizumab for Severe Liver Involvement With High Cardiac Output in Hereditary Hemorrhagic Telangiectasia Within the French Hereditary Hemorrhagic Telangiectasia Network
Hereditary Hemorrhagic Telangiectasia (HHT), Pulmonary Hypertension
RecruitingObservational study
The HIgh-fidelity Hydraulic couPling Upper-arm Cuff Assessment of Limits, Safety, and Effectiveness (HIPULSE) Trial (Cardiac Output Study)
ICU, Pulmonary Artery Catheter (PAC)
Recruiting
Intraoperative Multimodal Monitoring as a Means in Reducing the Duration of Mechanical Ventilation in High-Risk Patients Undergoing Major Abdominal Procedures - A Pilot Study
Major Abdominal Surgeries, Mechanical Ventilation
RecruitingObservational study
Effect of Labetalol, Atenolol, and Nifedipine on Maternal Hemodynamics Measured by ICG in Early Pregnancy
Systolic Hypertension, Pregnancy Related
Recruiting
Optimising HFO&VTV in Newborn Infants
High Frequency Oscillation, Volume Targeted Ventilation

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. This study is not recruiting at the moment.

Jan Bakker, PhD study chair

Erasmus University Hospital Rotterdam The Netherlands

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 Cardiac Output, High, run by Catharina Ziekenhuis Eindhoven at 1 site in Netherlands.

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 1 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 19 May 2016. 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 Netherlands. 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?

Mean systemic filling pressure (Pms) (time frame: 1 hour). 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 NCT02060942, which also lists 21 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 19 May 2016.