Intraoperative Haemodynamic Optimization Comparing Flow and Pressure Parameters

NCT02104687 | Completed

• 2 other identifiers: FNO-KARIM-1SGS05/LF/2014
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

GTD, goal-directed haemodynamic therapy; CI, cardiac index; MAP, mean arterial pressure; CVP, central venous pressure

Outcome Measures

Primary Outcomes (1)

• Pre-defined postoperative complications for up to 28 days after surgery

  The followed postoperative complications include infectious, respiratory, cardiovascular, abdominal, renal complications, massive postoperative bleeding and preoperative death.

  24 months

Secondary Outcomes (1)

• The length of hospitalization

  24 months

Study Arms (2)

Flow

ACTIVE COMPARATOR

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.

Procedure: Press group

Press

ACTIVE COMPARATOR

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.

Procedure: Flow group

Interventions

Flow group PROCEDURE

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

Press

Press group PROCEDURE

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

Flow

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Ostrava: lead

Study Sites (1)

University Hospital Ostrava

Ostrava, 70852, Czechia

Location

Related Publications (2)

• 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.

  PMID: 8319478 BACKGROUND

• 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.

  PMID: 20966436 BACKGROUND

Study Officials

• Pavel Szturz, MD, Ph.D.

  University Hospital Ostrava

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2014
• First Posted: April 4, 2014
• Study Start: April 1, 2014
• Primary Completion: June 1, 2016
• Study Completion: August 1, 2016
• Last Updated: September 8, 2016

Record last verified: 2016-09

Locations

CZ (1)