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Cardiac SurgeryNCT04482946

Dynamic Tests and Parameters to Predict Fluid Responsiveness After OPCAB

A study testing Assessment of fluid responsiveness in people with Cardiac Surgery, run by Northern State Medical University at 1 site in Russia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Objective: To assess the predictive value of dynamic tests and parameters for evaluation of fluid responsiveness after off-pump coronary artery bypass grafting (OPCAB). After arrival to ICU, all patients received positive end-expiratory pressure test (PEEP-test), mini-fluid challenge test (mFCT) and standard fluid… Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Cardiac Surgery
What is being tested?
Assessment of fluid responsiveness
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
1 siteRussia
Study dates
Jan 2015to Jan 2021
Phase
Interventional
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
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • elective OPCAB

Who cannot join

  • morbid obesity with body mass index > 40 kg/m2 constant atrial fibrillation.

Trial locations and contacts

1 site in 1 country.

Mikhail Y Kirov, PhD contact

mikhail_kirov@hotmail.com

Eugenia V Fot contact

89212950685

ev_fot@mail.ru

Russia1 site, 1 recruiting
  • City Hospital # 1 n.a. E.E. Volosevich

    Arkhangelsk, 163000

    Mikhail Kirov, PhD, mikhail_kirov@hotmail.com

    Recruiting

Other trials in Russia

About this study

Official title: Dynamic Tests and Parameters to Predict Fluid Responsiveness After Off-pump Coronary Artery Bypass Grafting

Objective: To assess the predictive value of dynamic tests and parameters for evaluation of fluid responsiveness after off-pump coronary artery bypass grafting (OPCAB).

After arrival to ICU, all patients received positive end-expiratory pressure test (PEEP-test), mini-fluid challenge test (mFCT) and standard fluid challenge test (sFCT) to assess fluid responsiveness. In addition, investigators measured pulse pressure variation using two monitoring systems (PPVPiCCO and PPVNK), stroke volume variation (SVV), heart-lung interaction index (HLI) and plethysmogram variability index (PVI) before and after sFCT.

Read the detailed description

All patients were intubated using the standard induction technique with sodium thiopental (4 mg/kg), fentanyl (2.5-3.0 mcg/kg) and pipecuronium bromide (0.1 mg/kg). Anaesthesia was maintained using sevoflurane (0.5-3.0 vol.% at the end of expiration) and fentanyl (2.0-4.0 mcg/kg/hr). Depth of anaesthesia was adjusted to maintain bispectral index (BIS) values between 40-60 (LifeScope, Nihon Kohden, Japan).

In all cases, preoxygenation with 80% O2 was provided during 3-5 minutes before anesthesia. After tracheal intubation, patients were ventilated using a protective volume-controlled mode (Dräger Primus, Germany) with tidal volume of 6-8 mL/kg of predicted body weight, flow of 1 L/min and positive end-expiratory pressure (PEEP) of 5 cm H2O. The value of FiO2 was set to at least 50% or higher to achieve intraoperative SpO2 above 95%. The respiratory rate was adjusted to maintain end-tidal CO2 values within 30-35 mm Hg.

All the patients were operated by the same team of surgeons using Acrobat SUV OM-9000S (Guidant, Santa Clara, USA) device for stabilization of the heart during revascularization.

After surgery, all patients were transferred to the postoperative cardiac ICU and sedated during 60 min with continuous infusion of propofol (2-4 mcg/kg/hr) to maintain BIS values within 60-70. Respiratory support in ICU was continued by a G5 ventilator (Hamilton Medical, Switzerland) using pressure controlled ventilation mode with parameters same as for intraoperative period.

Investigators provided invasive hemodynamic monitoring (PiCCO2, Pulsion Medical Systems, Germany; Nihon Kohden, MU-671RK, Japan) to all patients. After the initial stabilization of patient, investigators performed three dynamic tests in a consequent order. The positive end-expiratory pressure test (PEEP-test) consisted of a transient increase of PEEP from 5 to 20 cm H2O during 120 seconds. The PEEP-test was interrupted if mean arterial pressure (MAP) decreased below 55 mm Hg and/or pulse contour cardiac index (PCCI) decreased below 1.5 L/min/m2. Mini-fluid challenge test (mFCT) consisted of rapid infusion of crystalloids 1.5 mL/kg during 120 seconds. Thereafter, all patients received fluid challenge (standard fluid challenge test, sFCT). During the sFCT, patients received 7 mL/kg of crystalloids within 10 minutes. During PEEP-test and mFCT, investigators performed continuous monitoring of MAP, SVV, PPV and PCCI (PiCCO2). Investigators also measured SVV, PPVPiCCO, PVVNK (Nihon Kohden), HLI (Hamilton G-5, Switzerland) and PVI (Masimo, USA) before and after sFCT. In addition, investigators assessed cardiac index (CI), extravascular lung water index (EVLWI) and global end-diastolic volume index (GEDVI) using transpulmonary thermodilution (PiCCO2). During the study, investigators measured arterial blood gases and lactate concentration. The patients who demonstrated an increase in CI ≥ 15 % after sFCT were defined as fluid responders.10, 11 After the initial measurements, sedation was stopped, and the weaning from respiratory support was initiated. The weaning protocol included gradual decrease of inspiratory pressure and mandatory respiratory rate followed by spontaneous breathing trial after achieving pressure support of 8 cm H2O. After passing the 30-min spontaneous breathing trial, all the patients were extubated and received oxygen inhalation via facial mask.

In addition to hemodynamic and respiratory parameters, recorded the preoperative EuroScore II, duration of postoperative mechanical ventilation, length of ICU stay and fluid balance after OPCAB and on postoperative Day 1.

Conditions
Cardiac Surgery
Being tested
Assessment of fluid responsiveness
Keywords
fluid responsiveness, dynamic tests, dynamic parameters

What participants receive

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

  • Assessment of fluid responsivenessDiagnostic test

    The positive end-expiratory pressure test (PEEP-test) consisted of a transient increase of PEEP from 5 to 20 cm H2O for 120 seconds. The PEEP-test was interrupted if MAP decreased below 55 mm Hg and/or pulse contour cardiac index (PCCI) decreased below 1.5 L/min/m2. Mini-fluid challenge test (mFCT) consisted of rapid infusion of crystalloids 1.5 mL/kg during 120 seconds. Thereafter, all patients received fluid challenge (standard fluid challenge test, sFCT). During the sFCT, patients received 7 mL/kg of crystalloids within 10 minutes. Investigators performed monitoring of mean arterial pressure (MAP), SVV and PPVPiCCO using femoral artery (PiCCO2). Investigators also assessed PVVNK using radial artery and Nihon Kohden patient monitor. HLI (Hamilton G-5, Switzerland) and PVI (Masimo, USA) were assessed non-invasively, using finger probes.

Study groups in NCT04482946
Study groupRoleWhat they receive
Assessment of fluid responsivenessExperimentalThe positive end-expiratory pressure test (PEEP-test) consisted of a transient increase of PEEP from 5 to 20 cm H2O for 120 seconds. The PEEP-test was interrupted if MAP decreased below 55 mm Hg and/or pulse contour cardiac index (PCCI) decreased below 1.5 L/min/m2. Mini-fluid challenge test (mFCT) consisted of rapid infusion of crystalloids 1.5 mL/kg during 120 seconds. Thereafter, all patients received fluid challenge (standard fluid challenge test, sFCT). During the sFCT, patients received 7 mL/kg of crystalloids within 10 minutes. Investigators performed monitoring of mean arterial pressure (MAP), SVV and PPVPiCCO using femoral artery (PiCCO2). Investigators also assessed PVVNK using radial artery and Nihon Kohden patient monitor. HLI (Hamilton G-5, Switzerland) and PVI (Masimo, USA) were assessed non-invasively, using finger probes.
Receives: Diagnostic Test: Assessment of fluid responsiveness

What is being measured

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

  1. Predictive value of dynamic tests

    To assess if changes in mean arterial pressure, pulse pressure variation and stroke volume variation by more than 10% during the PEEP-test and mini fluid challenge test can predict the increment of the cardiac output on more than 15 % during standard fluid challenge test after off-pump coronary artery bypass grafting (OPCAB).

    Measured: immediately postoperatively

Secondary outcomes (1)
  1. Predictive value of dynamic parameters

    To assess the ability of the decrement of Pulse pressure variation (measured by Nikhon), Heart-lung interaction index (HLI) and Pulse variability index (PVI) by more than 3% to predict the increment of the cardiac output on more than 15 % during standard fluid challenge test after off-pump coronary artery bypass grafting (OPCAB).

    Measured: immediately postoperatively

Timeline

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

  1. First posted23 Jul 2020
  2. Study startJan 2015
  3. Primary completionJan 2016
  4. Study completionJan 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
32 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04482946
Sponsor's protocol ID
Dyn Test-and-Index
Status last verified
Jul 2020
First submitted
15 Jul 2020
Last updated
23 Jul 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Assessment of fluid responsiveness in people with Cardiac Surgery, run by Northern State Medical University at 1 site in Russia.

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: status not confirmed, as of the sponsor's last update on 23 Jul 2020. 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 Russia. 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?

Results are not available in the source record.

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

Contact Mikhail Y Kirov, PhD (mikhail_kirov@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Predictive value of dynamic tests (time frame: immediately postoperatively). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 23 Jul 2020.

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