Intraoperative Haemodynamic Optimization Comparing Flow and Pressure Parameters

NCT ID: NCT02104687

Last Updated: 2016-09-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-04-30
• Study Completion Date: 2016-08-31

Brief Summary

The purpose of the study is to confirm the hypothesis that flow treatment algorithm based on cardiac index trending by transesophageal Dopplerometry would result in reduced complications and reduced length of hospital stay in major abdominal surgery patients, when compared to patients treated with press treatment algorithm.

Detailed Description

Despite standardisation of intraoperative care provided for risk surgery patients, the preoperative mortality remains higher than expected. The aim of the goal-directed heamodynamic therapy (GDT) is to improve the altered cardiovascular function and to reach the desired intraoperative values of oxygen supply (DO2) and cardiac index (CI). Standard haemodynamic measurements, such as heart rate (HR), mean arterial pressure (MAP) and central venous pressure (CVP) remain relatively unchanged despite reduced blood flow. However, GTD is able to detect early hypo perfusion abnormalities. The aim of goal-directed heamodynamic therapy, based on the titration of fluids and vasoactive drugs to physiological flow-related end points is to reduce perioperative complications, perioperative morbidity and mortality. We hypothesise, that following this treatment regimen results in reduced postoperative complications (primary endpoint) and reduced length of hospital stay (secondary endpoint).

Conditions

Major Abdominal Surgery; Duodenohemipancreatectomy; Rectal Resection; Extensive Bowel Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Flow

The Flow therapeutic algorithm will be responsible for adjustment of intraoperative interventions - volumotherapy and administration of vasoactive drugs, with the aim to maintain the CI value \>2.5 l/m/m2 (FTc - flow time \<330 ms was chosen as variable defining preload; PV, peak velocity \<70 ms-1 will be used as a variable defining contractility; SVR, total systemic vascular resistance between 1000-1800 cdyn.s/cm5m2 will be used as variable defining after load). After the desired values of CI have been obtained, no further increase of therapeutic intervention (fluids, vasoactive drugs) will be performed.

Group Type: ACTIVE_COMPARATOR

Press group

Intervention Type: PROCEDURE

After induction, the parameters of MAP and CVP will be monitored in each of the patients.

Press

The Press therapeutic algorithm will be responsible for adjustment of intraoperative interventions based upon standard pressure parameters and will include volumotherapy and administration of vasoactive drugs, with the aim to maintain the desired values of MAP of 65-105 mmHg and CVP 8-12 mmHg. After the desired values of MAP and CVP have been obtained, no further increase of therapeutic intervention (fluids, vasoactive drugs) will be performed.

Group Type: ACTIVE_COMPARATOR

Flow group

Intervention Type: PROCEDURE

After induction, each patient will obtain Transesophageal Dopplerometry probe (CardioQ) in order to monitor the parameters of CI, FTc, PV and SVR.

Interventions

Flow group

After induction, each patient will obtain Transesophageal Dopplerometry probe (CardioQ) in order to monitor the parameters of CI, FTc, PV and SVR.

Intervention Type: PROCEDURE

Press group

After induction, the parameters of MAP and CVP will be monitored in each of the patients.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 21 years of age and above
• anticipated duration of surgery more than 120 minutes
• estimated blood loss exceeding more than 15% of blood volume
• American Society of Anesthesiology (ASA) classification 2 or 3
• indication for an arterial line and central venous catheter

Exclusion Criteria

• pregnant or lactating women
• age below 21 years of age
• emergency surgery
• American Society of Anesthesiology (ASA) classification 1
• sepsis and septic shock
• severe cardiac arrhythmias
• patients with pathology or intervention on oesophagus

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital Ostrava

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pavel Szturz, MD, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University Hospital Ostrava

Locations

University Hospital Ostrava

Ostrava, , Czechia

Countries

Czechia

References

Shoemaker WC, Appel PL, Kram HB. Hemodynamic and oxygen transport responses in survivors and nonsurvivors of high-risk surgery. Crit Care Med. 1993 Jul;21(7):977-90. doi: 10.1097/00003246-199307000-00010.

Reference Type: BACKGROUND

PMID: 8319478 (View on PubMed)

Hamilton MA, Cecconi M, Rhodes A. A systematic review and meta-analysis on the use of preemptive hemodynamic intervention to improve postoperative outcomes in moderate and high-risk surgical patients. Anesth Analg. 2011 Jun;112(6):1392-402. doi: 10.1213/ANE.0b013e3181eeaae5. Epub 2010 Oct 21.

Reference Type: BACKGROUND

PMID: 20966436 (View on PubMed)

Other Identifiers

SGS05/LF/2014

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

FNO-KARIM-1

Identifier Type: -

Identifier Source: org_study_id