Intraoperative Haemodynamic Optimization Comparing Flow and Pressure Parameters

Major Abdominal Surgery Clinical Trial

— Flow-press  

Official title:

The Influence of Intraoperative Goal-directed Hemodynamic Therapy Based on Cardiac Index Trending on the Volume of Intraoperatively Administered Fluids and Vasoactive Agents in Comparison to Standard Pressure Monitoring in Patients Undergoing Major Elective Abdominal Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02104687
• Other study ID #: FNO-KARIM-1
• Secondary ID: SGS05/LF/2014
• Status: Completed
• Phase: N/A
• First received: April 1, 2014
• Last updated: September 7, 2016
• Start date: April 2014
• Est. completion date: August 2016

Study information

• Verified date: September 2016
• Source: University Hospital Ostrava
• Contact: n/a
• Is FDA regulated: No
• Health authority: Czech Republic: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: August 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Procedure:
• Flow group
After induction, each patient will obtain Transesophageal Dopplerometry probe (CardioQ) in order to monitor the parameters of CI, FTc, PV and SVR.
• Press group
After induction, the parameters of MAP and CVP will be monitored in each of the patients.

Locations

Country	Name	City	State
Czech Republic	University Hospital Ostrava	Ostrava

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Ostrava

Country where clinical trial is conducted

Czech Republic, 

References & Publications (2)

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. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	The length of hospitalization	Length of hospital stay will be obtained from the patient record.	24 months	No