Mean Systemic Filling Pressure and Heart Performance Predicting Fluid Responsiveness

NCT02060942 | Completed

• 1 other identifier: M12-1271
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cardiac Output, High

Keywords

Volume responsiveness mean systemic filling pressure

Outcome Measures

Primary Outcomes (1)

• Mean systemic filling pressure (Pms)

  An increase in mean systemic filling pressure after (self)volume-challenge indicating volume responsiveness of the patient

  1 hour

Secondary Outcomes (1)

• Heart performance (eH)

  1 hour

Other Outcomes (12)

• Secondary hemodynamic parameters

  1 hour

• Secondary hemodynamic parameters

  1 hour

• Secondary hemodynamic parameters

  1 hour

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Catharina Ziekenhuis Eindhoven: lead
• Erasmus Medical Center: collaborator

Study Sites (1)

Catharina Hospital

Eindhoven, North Brabant, 5623 EJ, Netherlands

Location

Related Publications (21)

• 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.

  PMID: 19002596 BACKGROUND

• 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.

  PMID: 22185905 BACKGROUND

• 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.

  PMID: 12065368 BACKGROUND

• 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.

  PMID: 16540963 BACKGROUND

• 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.

  PMID: 21948105 BACKGROUND

• 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.

  PMID: 19237896 BACKGROUND

• 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.

  PMID: 6016029 BACKGROUND

• 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.

  PMID: 8458763 BACKGROUND

• 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.

  PMID: 13649920 BACKGROUND

• 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.

  PMID: 13218155 BACKGROUND

• 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.

  PMID: 14376522 BACKGROUND

• 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.

  PMID: 13458395 BACKGROUND

• Parkin WG. Volume state control - a new approach. Crit Care Resusc. 1999 Sep;1(3):311-21.

  PMID: 16603021 BACKGROUND

• 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.

  PMID: 21485666 BACKGROUND

• 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.

  PMID: 20168223 BACKGROUND

• Maas JJ, Pinsky MR, Geerts BF, de Wilde RB, Jansen JR. Estimation of mean systemic filling pressure in postoperative cardiac surgery patients with three methods. Intensive Care Med. 2012 Sep;38(9):1452-60. doi: 10.1007/s00134-012-2586-0. Epub 2012 May 15.

  PMID: 22584797 BACKGROUND

• Lang RM, Bierig M, Devereux RB, Flachskampf FA, Foster E, Pellikka PA, Picard MH, Roman MJ, Seward J, Shanewise JS, Solomon SD, Spencer KT, Sutton MS, Stewart WJ; Chamber Quantification Writing Group; American Society of Echocardiography's Guidelines and Standards Committee; European Association of Echocardiography. Recommendations for chamber quantification: a report from the American Society of Echocardiography's Guidelines and Standards Committee and the Chamber Quantification Writing Group, developed in conjunction with the European Association of Echocardiography, a branch of the European Society of Cardiology. J Am Soc Echocardiogr. 2005 Dec;18(12):1440-63. doi: 10.1016/j.echo.2005.10.005. No abstract available.

  PMID: 16376782 BACKGROUND

• Oren-Grinberg A. The PiCCO Monitor. Int Anesthesiol Clin. 2010 Winter;48(1):57-85. doi: 10.1097/AIA.0b013e3181c3dc11. No abstract available.

  PMID: 20065727 BACKGROUND

• Bakker J, Damen J, van Zanten AR, Hubben JH; Protocollencommissie Nederlandse Vereiniging voor Intensive Care. [Admission and discharge criteria for intensive care departments]. Ned Tijdschr Geneeskd. 2003 Jan 18;147(3):110-5. Dutch.

  PMID: 12577770 BACKGROUND

• Jabot J, Teboul JL, Richard C, Monnet X. Passive leg raising for predicting fluid responsiveness: importance of the postural change. Intensive Care Med. 2009 Jan;35(1):85-90. doi: 10.1007/s00134-008-1293-3. Epub 2008 Sep 16.

  PMID: 18795254 BACKGROUND

• Jolly SS, Yusuf S, Cairns J, Niemela K, Xavier D, Widimsky P, Budaj A, Niemela M, Valentin V, Lewis BS, Avezum A, Steg PG, Rao SV, Gao P, Afzal R, Joyner CD, Chrolavicius S, Mehta SR; RIVAL trial group. Radial versus femoral access for coronary angiography and intervention in patients with acute coronary syndromes (RIVAL): a randomised, parallel group, multicentre trial. Lancet. 2011 Apr 23;377(9775):1409-20. doi: 10.1016/S0140-6736(11)60404-2. Epub 2011 Apr 4.

  PMID: 21470671 BACKGROUND

MeSH Terms

Conditions

Cardiac Output, High

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jan Bakker, PhD

  Erasmus University Hospital Rotterdam The Netherlands

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD-candidate Intensive Care Unit / resident cardiology

Study Record Dates

• First Submitted: August 23, 2013
• First Posted: February 12, 2014
• Study Start: August 1, 2013
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: May 19, 2016

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)