Implementation of Computer-Assisted Intraoperative Goal-Directed Fluid Therapy

Major Abdominal Surgery Clinical Trial

Official title:

Implementation of Computer-Assisted Intraoperative Goal-Directed Fluid Therapy in Major Abdominal Surgery: A Before and After Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02978430
• Other study ID #: P2016/334
• Status: Completed
• Phase: Phase 2
• First received: November 22, 2016
• Last updated: March 9, 2017
• Start date: April 2015
• Est. completion date: January 2017

Study information

• Verified date: November 2016
• 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 the implementation of computer-assisted goal directed fluid therapy (GDFT) to standard of care fluid therapy in major abdominal surgery.

Description:

Fluid therapy is one of the main tools used in anesthesiology to maintain adequate hemodynamic stability. Goal-directed fluid therapy (GDFT) based on cardiac output and/or dynamic parameters of fluid responsiveness (e.g. pulse pressure variation) has been shown to decrease post-operative complications. The main inconvenience of protocol based therapy is its technical complexity which requires considerable time, attention, and vigilance. GDFT assisted by a closed-loop system, when compared to manual GDFT, is associated with a longer preload independent state and could increase clinician adherence to protocol. To this day no study has compared closed-loop assisted GDFT to standard of care.

Goal:

This study compares the results of the study entitled "Crystalloids or Colloids for Goal directed Fluid Therapy With Closed-loop Assistance in Major Surgery" (NCT02312999) to a standard of care group (started retrospectively before the first included patient of the above study) where fluid therapy is based only on static variables (e.g. arterial pressure, heart rate, central venous pressure (CVP), and urine output.) These groups consisted of the same population undergoing the same types of surgery.

Hypothesis:

A protocolized approach using computer-assisted GDFT when compared to standard of care is associated with less fluid administration and less blood transfusions.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 260
• Est. completion date: January 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patients (over the age of 18) undergoing elective major abdominal surgery that is expected to take longer than 3 hours and requiring general anesthesia.

Exclusion Criteria:

• Patients under 18 years of age

• Patients not undergoing surgery, requiring anesthesia, or cardiac output monitoring

• Patients with arrhythmia and/or atrial fibrillation

• Patients who are allergic to HES (hydroxyethyl starch)

• Patients with renal insufficiency (serum creatinine of >2 mg/ml) or hepatic dysfunction (liver enzymes >1.5)

• Patients who has coagulation disorders (values higher than 1.5x normal values)

• Patients without the capacity to give written informed consent or refusal of consent

• Pregnancy at time of enrollment.

Related Conditions & MeSH terms

• Major Abdominal Surgery

Intervention

Device:
• Computer-assisted GDFT
Patients receive fluid therapy via a computer-assisted goal-directed fluid therapy (GDFT) prototype closed-loop (automated) system guided by a cardiac output monitor.

Other:
• Standard of care
Patients receive fluid management based only on static variables (e.g. arterial pressure, heart rate, CVP, and urine output). This control group (started retrospectively before the first included patient of the closed-loop goal directed fluid therapy group) consists of the same population undergoing the same surgery as the closed-loop GDFT group.

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 (4)

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

Salzwedel C, Puig J, Carstens A, Bein B, Molnar Z, Kiss K, Hussain A, Belda J, Kirov MY, Sakka SG, Reuter DA. Perioperative goal-directed hemodynamic therapy based on radial arterial pulse pressure variation and continuous cardiac index trending reduces postoperative complications after major abdominal surgery: a multi-center, prospective, randomized study. Crit Care. 2013 Sep 8;17(5):R191. doi: 10.1186/cc12885. — View Citation

Scheeren TW, Wiesenack C, Gerlach H, Marx G. Goal-directed intraoperative fluid therapy guided by stroke volume and its variation in high-risk surgical patients: a prospective randomized multicentre study. J Clin Monit Comput. 2013 Jun;27(3):225-33. doi: 10.1007/s10877-013-9461-6. — View Citation

Spanjersberg WR, Bergs EA, Mushkudiani N, Klimek M, Schipper IB. Protocol compliance and time management in blunt trauma resuscitation. Emerg Med J. 2009 Jan;26(1):23-7. doi: 10.1136/emj.2008.058073. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Perioperative fluid administration	Fluid balance during perioperative period	24 hours
Secondary	Length of hospitalisation		Every day up to 90 days after hospitalization
Secondary	Mortality rate		30 days
Secondary	Transfusion of blood products during hospitalization	In-hospital transfusion during hospitalization	Every day up to 90 days post surgery
Secondary	Hypotension incidence during surgery	Incidence of hypotension (defined as total case time spent with 20% drop from baseline preoperative blood pressure)	24 hours
Secondary	Need of vasopressor	Use of vasopressors during the perioperative period	24 hours
Secondary	Renal function - urea level	Urea levels. Measured in a blood sample taken during hospitalization	Every day up to 90 days after hospitalization
Secondary	Renal function - creatinine level	Creatinine levels. Measured in a blood sample taken during hospitalization	Every day up to 90 days after hospitalization
Secondary	Postoperative complications	Major complications included 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 included unplanned ICU admission, pneumonia/pleural effusion, deep venous thrombosis, paralytic ileus progressive, renal insufficiency, infection (superficial wound infection/fever/urinary infection) and confusion/delirium.	Every day up to 90 days after hospitalization