Dynamic Tests and Parameters to Predict Fluid Responsiveness After OPCAB

NCT04482946 | Unknown

• 1 other identifier: Dyn Test-and-Index
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Cardiac Surgery

Keywords

fluid responsiveness; dynamic tests; dynamic parameters

Outcome Measures

Primary Outcomes (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).

  immediately postoperatively

Secondary Outcomes (1)

• Predictive value of dynamic parameters

  immediately postoperatively

Study Arms (1)

Assessment of fluid responsiveness

EXPERIMENTAL

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.

Diagnostic Test: Assessment of fluid responsiveness

Interventions

Assessment of fluid responsiveness DIAGNOSTIC_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.

Assessment of fluid responsiveness

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• elective OPCAB

You may not qualify if:

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

Sponsors & Collaborators

• Northern State Medical University: lead

Study Sites (1)

City Hospital # 1 n.a. E.E. Volosevich

Arkhangelsk, 163000, Russia

RECRUITING

Central Study Contacts

Mikhail Y Kirov, PhD

CONTACT

mikhail_kirov@hotmail.com

Eugenia V Fot

CONTACT

89212950685; ev_fot@mail.ru

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the anesthesiology and intensive care department

Study Record Dates

• First Submitted: July 15, 2020
• First Posted: July 23, 2020
• Study Start: January 1, 2015
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2021
• Last Updated: July 23, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)