Automated Closed-Loop Versus Restrictive Fluid Therapy in Abdominal Surgery

Abdominal Laparoscopic and/or Robotic Surgery Clinical Trial

Official title:

Automated Closed-Loop Versus Restrictive Fluid Therapy in Abdominal Surgery: a Pilot Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03039946
• Other study ID #: P2016/526
• Status: Completed
• Phase: N/A
• First received: January 31, 2017
• Last updated: March 27, 2017
• Start date: January 2017
• Est. completion date: March 2017

Study information

• Verified date: January 2017
• Source: Erasme University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to compare hemodynamic variables and outcome in patients undergoing laparoscopic and/or robotic elective abdominal surgery. Patients will receive either an automated closed-loop goal-directed fluid therapy (GDFT) guided by non-invasive flow monitoring or a restrictive fluid therapy of 4ml/kg/h.

Description:

Perioperative fluid management is a topic of much debate that has intensified over recent years. Studies have shown improved postoperative outcomes with restricted fluid administration in the perioperative period for moderate risk abdominal surgery. They concluded that in patients undergoing elective abdominal surgery, intraoperative restrictive fluid management was associated with a reduction in postoperative morbidity and shortened hospital stay. Current standard practice is a crystalloid based fluid therapy guided by static hemodynamic parameters such as heart rate, blood pressure, and diuresis. However, several studies have criticized this cookbook approach and recommend tailoring management to specific physiologic dynamic endpoints such as stroke volume variation and cardiac output using a flow monitoring device. Our team has demonstrated that the use of a closed-loop system is feasible and allows precise titration of fluid administration in abdominal and vascular surgery using either a minimally or a non-invasive monitoring system.

Goal:

This study compares hemodynamic variables and outcome in patients who will receive either automated closed-loop fluid therapy guided by non-invasive flow monitoring or restrictive fluid therapy of 4ml/kg/h. Both groups consist of the same population undergoing laparoscopic and/or robotic surgery.

Hypothesis:

A closed-loop assisted intraoperative GDFT when compared to restrictive fluid therapy will provide better hemodynamic variables.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Laparoscopic and/or robotic elective abdominal surgery( colorectal, gynecological, urological)

Exclusion Criteria:

• Intraoperative invasive monitoring (arterial line)

• Open colorectal surgery (laparotomy)

• Emergency surgery

• Expected intraoperative blood loss greater than 1000ml

• Arrhythmia (e.g. atrial fibrillation)

Related Conditions & MeSH terms

• Abdominal Laparoscopic and/or Robotic Surgery

Intervention

Device:
• Closed-Loop GDFT
Patients receive fluids in the form of 100ml boluses of crystalloid (Plasmalyte) over 6 minutes via an automated closed-loop goal-directed fluid therapy (GDFT) system guided by non-invasive flow monitoring (Clearsight system). Additional boluses of colloid or crystalloid can be administered under the attending anesthesiologist's discretion (e.g. to compensate blood loss) .

Other:
• Restrictive Fluid Therapy
Patients receive fluids (Plasmalyte) via a restrictive approach with a baseline of of 4ml/kg/h. Additional boluses of colloid or crystalloid can be administered under the attending anesthesiologist's discretion (e.g. to compensate blood loss) .

Locations

Country	Name	City	State
Belgium	Erasme University Hospital	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Erasme University Hospital

Country where clinical trial is conducted

Belgium, 

References & Publications (3)

Donati A, Loggi S, Preiser JC, Orsetti G, Münch C, Gabbanelli V, Pelaia P, Pietropaoli P. Goal-directed intraoperative therapy reduces morbidity and length of hospital stay in high-risk surgical patients. Chest. 2007 Dec;132(6):1817-24. Epub 2007 Oct 9. — View Citation

Giglio MT, Marucci M, Testini M, Brienza N. Goal-directed haemodynamic therapy and gastrointestinal complications in major surgery: a meta-analysis of randomized controlled trials. Br J Anaesth. 2009 Nov;103(5):637-46. doi: 10.1093/bja/aep279. Review. — View Citation

Rinehart J, Lilot M, Lee C, Joosten A, Huynh T, Canales C, Imagawa D, Demirjian A, Cannesson M. Closed-loop assisted versus manual goal-directed fluid therapy during high-risk abdominal surgery: a case-control study with propensity matching. Crit Care. 2015 Mar 19;19:94. doi: 10.1186/s13054-015-0827-7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Preload independent state	The percentage intraoperative time spent with stroke volume variation < 13% and/or cardiac index > 2.4 L/min/m2	6 hours
Secondary	Additional fluids administered intraoperatively		6 hours
Secondary	Number of closed-loop override by the attending anesthesiologist		6 hours
Secondary	Hospital length of stay		up to 90 days post surgery
Secondary	Postoperative complications	Major complications include cardiac (acute coronary syndrome/ arrhythmia), pulmonary (embolism/edema), gastrointestinal (bowel and surgical anastomotic leak/internal or external fistulas/peritoneal effusions), renal (renal failure requiring dialysis), infectious (peritonitis/ sepsis), coagulation (bleeding), wound dehiscence, stroke, reoperation, readmission, and death.; Minor complications include unplanned ICU admission, pneumonia/pleural effusion, deep venous thrombosis, paralytic ileus, renal insufficiency, infection (superficial wound infection/fever/urinary infection) and confusion/delirium.	up to 90 days after hospitalization