Prediction of Volume Responsiveness in Presence of Left Ventricular Diastolic Dysfunction

NCT02441621 | Unknown DMC

• 1 other identifier: AZ-139
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The ability of the global end-diastolic volume index (GEDVI), stroke volume variation (SVV) and pulse pressure variation (PPV) for prediction of fluid responsiveness in presence of left ventricular diastolic dysfunction is still unknown. The aim of the present study was to challenge the predictive power of GEDVI, SVV and PPV in cardiac surgery patients undergoing aortic valve replacement.

Conditions

Hemodynamics

Keywords

fluid responsiveness; diastolic dysfunction; left ventricular

Outcome Measures

Primary Outcomes (1)

• Increase in stroke volume index (SVI) >15%

  In presence of an increase of SVI \>15% during PLR and/or 500 ml crystalloids, patients are defined as responders.

  Patients will be obtained until the end of the operation, an expected average of 5 hours

Study Arms (7)

Passive leg raising

OTHER

Other: passive leg raising

premedication

OTHER

Other: premedication

intubation and mechanical ventilation

OTHER

Other: intubation and mechanical ventilation

central venous catheter

OTHER

Other: central venous catheter

arterial catheter

OTHER

Continuous monitoring is performed including electrocardiogram, radial arterial pressure catheter

Other: arterial catheter

transesophageal echocardiography

OTHER

Other: transesophageal echocardiography

transpulmonary thermodilution catheter

OTHER

Other: transpulmonary thermodilution catheter

Interventions

passive leg raising OTHER

The passive leg raising maneuver (PLR) involves a leg elevation up to 45° with the trunk in a horizontal position and is performed to induce hemodynamic effects by a volume challenge, turning unstressed blood volume to stressed volume proportional to body size.

Passive leg raising

premedication OTHER

patients receive premedication with midazolam 7.5 mg p.o.

premedication

intubation and mechanical ventilation OTHER

After induction of anesthesia with sufentanil (0.5 µg/kg) and propofol (1.5 mg/kg), orotracheal intubation is facilitated with rocuronium (0.6 mg/kg). Anesthesia is maintained with sufentanil (1 µg/kg/h) and propofol (3 mg/kg/h) and patients are ventilated with an oxygen/air mixture in volume-controlled mode, using a tidal volume of 8 ml/kg related to the ideal body weight. Positive end-expiratory pressure is set at 5 cmH2O.

intubation and mechanical ventilation

central venous catheter OTHER

a central venous catheter in the right or left internal jugular vein.

central venous catheter

arterial catheter OTHER

Continuous monitoring is performed including electrocardiogram, radial arterial pressure catheter

arterial catheter

transesophageal echocardiography OTHER

Before placement of a transpulmonary thermodilution catheter a transesophageal echocardiography (TOE) is performed. TOE is used to detect diastolic dysfunction of the left ventricle and to exclude right ventricular dysfunction.

transesophageal echocardiography

transpulmonary thermodilution catheter OTHER

In presence of left ventricular dysfunction a transpulmonary thermodilution catheter is placed in the femoral artery and connected to a PiCCO2 monitor (PiCCO2, Pulsion Medical Systems, Munich, Germany).

transpulmonary thermodilution catheter

Eligibility Criteria

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

You may qualify if:

• Patients \> 18 yrs of age
• Patients with a left ventricular ejection fraction ≥0.5
• Patients with left ventricular diastolic dysfunction.

You may not qualify if:

• Emergency procedures
• Right ventricular dysfunction
• Hemodynamic instability requiring pharmacologic Support
• Ongoing arrhythmia
• Intracardiac Shunts
• Severe mitral stenosis or insufficiency
• Aortic aneurysm \> 4 cm
• Use of an artificial left ventricular assist device or intra - aortic balloon pump.

Sponsors & Collaborators

• University Hospital Schleswig-Holstein: lead

Study Sites (1)

Ole Broch

Kiel, Schleswig-Holstein, 24105, Germany

Location

Related Publications (9)

• Rex S, Schalte G, Schroth S, de Waal EE, Metzelder S, Overbeck Y, Rossaint R, Buhre W. Limitations of arterial pulse pressure variation and left ventricular stroke volume variation in estimating cardiac pre-load during open heart surgery. Acta Anaesthesiol Scand. 2007 Oct;51(9):1258-67. doi: 10.1111/j.1399-6576.2007.01423.x. Epub 2007 Aug 20.

  PMID: 17714575 BACKGROUND

• Hofer CK, Muller SM, Furrer L, Klaghofer R, Genoni M, Zollinger A. Stroke volume and pulse pressure variation for prediction of fluid responsiveness in patients undergoing off-pump coronary artery bypass grafting. Chest. 2005 Aug;128(2):848-54. doi: 10.1378/chest.128.2.848.

  PMID: 16100177 BACKGROUND

• Marik PE, Cavallazzi R, Vasu T, Hirani A. Dynamic changes in arterial waveform derived variables and fluid responsiveness in mechanically ventilated patients: a systematic review of the literature. Crit Care Med. 2009 Sep;37(9):2642-7. doi: 10.1097/CCM.0b013e3181a590da.

  PMID: 19602972 BACKGROUND

• Renner J, Gruenewald M, Brand P, Steinfath M, Scholz J, Lutter G, Bein B. Global end-diastolic volume as a variable of fluid responsiveness during acute changing loading conditions. J Cardiothorac Vasc Anesth. 2007 Oct;21(5):650-4. doi: 10.1053/j.jvca.2007.05.006. Epub 2007 Jul 16.

  PMID: 17905268 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

• Osman D, Ridel C, Ray P, Monnet X, Anguel N, Richard C, Teboul JL. Cardiac filling pressures are not appropriate to predict hemodynamic response to volume challenge. Crit Care Med. 2007 Jan;35(1):64-8. doi: 10.1097/01.CCM.0000249851.94101.4F.

  PMID: 17080001 BACKGROUND

• Mahjoub Y, Pila C, Friggeri A, Zogheib E, Lobjoie E, Tinturier F, Galy C, Slama M, Dupont H. Assessing fluid responsiveness in critically ill patients: False-positive pulse pressure variation is detected by Doppler echocardiographic evaluation of the right ventricle. Crit Care Med. 2009 Sep;37(9):2570-5. doi: 10.1097/CCM.0b013e3181a380a3.

  PMID: 19623051 BACKGROUND

• Cioffi G, Mazzone C, Barbati G, Rossi A, Nistri S, Ognibeni F, Tarantini L, Di Lenarda A, Faggiano P, Pulignano G, Stefenelli C, de Simone G, Devereux RB. Combined circumferential and longitudinal left ventricular systolic dysfunction in patients with asymptomatic aortic stenosis. Echocardiography. 2015 Jul;32(7):1064-72. doi: 10.1111/echo.12825. Epub 2014 Nov 5.

  PMID: 25370995 BACKGROUND

• Rader F, Sachdev E, Arsanjani R, Siegel RJ. Left ventricular hypertrophy in valvular aortic stenosis: mechanisms and clinical implications. Am J Med. 2015 Apr;128(4):344-52. doi: 10.1016/j.amjmed.2014.10.054. Epub 2014 Nov 25.

  PMID: 25460869 BACKGROUND

MeSH Terms

Interventions

Premedication; Intubation; Respiration, Artificial; Central Venous Catheters

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics; Investigative Techniques; Airway Management; Resuscitation; Emergency Treatment; Respiratory Therapy; Vascular Access Devices; Catheters; Equipment and Supplies

Study Officials

• Ole Broch, MD

  Consultant anesthetist

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ole Broch, MD

CONTACT

+49 431-5972990; ole.broch@uksh.de

Jochen Renner, MD

CONTACT

+49 4315972991; jochen.renner@uksh.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: April 28, 2015
• First Posted: May 12, 2015
• Study Start: June 1, 2015
• Primary Completion: May 1, 2016
• Study Completion: June 1, 2016
• Last Updated: May 12, 2015

Record last verified: 2015-05

Locations

DE (1)