NCT02312999

Brief Summary

Study goal: This study will examine whether there is a significant difference in postoperative outcomes between GDFT using a colloid solution versus a crystalloid solution. Hypothesis: Perioperative fluid optimization through the use of a closed-loop assistance with a balanced starch solution (volulyte®) will be associated with a decrease in postoperative complications compared to the same approach using a balanced crystalloid solution (Plasmalyte®). Objective: To establish which kind of intravenous fluid used for goal directed therapy with closed-loop assistance will reduce the number of postoperative complications (evaluation made by the POMS score).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P50-P75 for phase_4 surgery

Timeline
Completed

Started Feb 2015

Typical duration for phase_4 surgery

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 5, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 9, 2014

Completed
3 months until next milestone

Study Start

First participant enrolled

February 24, 2015

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 21, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 21, 2017

Completed
Last Updated

January 19, 2018

Status Verified

January 1, 2018

Enrollment Period

2.8 years

First QC Date

December 5, 2014

Last Update Submit

January 18, 2018

Conditions

Surgery

Keywords

laparotomyplasma-Lytevolulyteclose loopabdominal surgery

Outcome Measures

Primary Outcomes (1)

  • POMS score

    Difference between the 2 groups in postoperative morbidity identified with the Post-Operative Morbidity Survey (POMS score) on postoperative days 2.

    48 hours

Secondary Outcomes (17)

  • Mortality rate

    30 days

  • Length of hospitalisation

    every day up to 90 days after hospitalisation

  • Quantity of fluid administered during surgery

    24 hours

  • Transfusion rate

    8 days

  • Hypotension incidence

    8 days

  • +12 more secondary outcomes

Study Arms (2)

Volulyte

EXPERIMENTAL

A baseline crystalloid infusion (plasmalyte®) will be set by the attending physician at 3 cc/kg/hr (standard patient care) for each of the randomized groups. The patient will receive fluid management via a closed loop (automated) system that will use an infusion pump (Q-Core) and a controller (a computer run index and algorithm developed by Sironis) to standardize the way fluids are administered intra-operatively and eliminate variation between clinical providers. The liquid perfused will be bolus amounts of volulyte.

Drug: Volulyte

Plasma-Lyte

ACTIVE COMPARATOR

A baseline crystalloid infusion (plasmalyte®) will be set by the attending physician at 3 cc/kg/hr (standard patient care) for each of the randomized groups. The patient will receive fluid management via a closed loop (automated) system that will use an infusion pump (Q-Core) and a controller (a computer run index and algorithm developed by Sironis) to standardize the way fluids are administered intra-operatively and eliminate variation between clinical providers. The liquid perfused will be bolus amounts of plasma-lyte.

Drug: Plasmalyte

Interventions

PlasmalyteDRUG
Plasma-Lyte
VolulyteDRUG
Volulyte

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients (over the age of 18) undergoing elective major abdominal surgery that is expected to take longer than 3 hours and requiring a general anesthesia and a minimally invasive cardiac output monitoring (Vigileo/Flotrac)
  • Patients who provide written informed consent

You may not qualify if:

  • 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
  • Patients with renal insufficiency (serum creatinine of \>2 mg/ml) or hepatic dysfunction (liver enzymes \>1.5)
  • Patients who has coagulation disorders (please define: values higher than 1.5x normal values
  • Patients without the capacity to give written informed consent or refusal of consent
  • Patients included in another protocol within a period of 3 months or Participating in another randomised trial
  • Pregnancy at time of enrolment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

CHU Brugmann

Brussels, 1020, Belgium

Location

Erasme

Brussels, 1070, Belgium

Location

Related Publications (6)

  • Feldheiser A, Pavlova V, Bonomo T, Jones A, Fotopoulou C, Sehouli J, Wernecke KD, Spies C. Balanced crystalloid compared with balanced colloid solution using a goal-directed haemodynamic algorithm. Br J Anaesth. 2013 Feb;110(2):231-40. doi: 10.1093/bja/aes377. Epub 2012 Oct 30.

    PMID: 23112214BACKGROUND

  • Silva JM Jr, de Oliveira AM, Nogueira FA, Vianna PM, Pereira Filho MC, Dias LF, Maia VP, Neucamp Cde S, Amendola CP, Carmona MJ, Malbouisson LM. The effect of excess fluid balance on the mortality rate of surgical patients: a multicenter prospective study. Crit Care. 2013 Dec 10;17(6):R288. doi: 10.1186/cc13151.

    PMID: 24326085BACKGROUND

  • Perner A, Haase N, Guttormsen AB, Tenhunen J, Klemenzson G, Aneman A, Madsen KR, Moller MH, Elkjaer JM, Poulsen LM, Bendtsen A, Winding R, Steensen M, Berezowicz P, Soe-Jensen P, Bestle M, Strand K, Wiis J, White JO, Thornberg KJ, Quist L, Nielsen J, Andersen LH, Holst LB, Thormar K, Kjaeldgaard AL, Fabritius ML, Mondrup F, Pott FC, Moller TP, Winkel P, Wetterslev J; 6S Trial Group; Scandinavian Critical Care Trials Group. Hydroxyethyl starch 130/0.42 versus Ringer's acetate in severe sepsis. N Engl J Med. 2012 Jul 12;367(2):124-34. doi: 10.1056/NEJMoa1204242. Epub 2012 Jun 27.

    PMID: 22738085BACKGROUND

  • Cannesson M. Arterial pressure variation and goal-directed fluid therapy. J Cardiothorac Vasc Anesth. 2010 Jun;24(3):487-97. doi: 10.1053/j.jvca.2009.10.008. No abstract available.

    PMID: 20022261BACKGROUND

  • Ramsingh DS, Sanghvi C, Gamboa J, Cannesson M, Applegate RL 2nd. Outcome impact of goal directed fluid therapy during high risk abdominal surgery in low to moderate risk patients: a randomized controlled trial. J Clin Monit Comput. 2013 Jun;27(3):249-57. doi: 10.1007/s10877-012-9422-5. Epub 2012 Dec 22.

    PMID: 23264068BACKGROUND

  • Pearse RM, Harrison DA, MacDonald N, Gillies MA, Blunt M, Ackland G, Grocott MP, Ahern A, Griggs K, Scott R, Hinds C, Rowan K; OPTIMISE Study Group. Effect of a perioperative, cardiac output-guided hemodynamic therapy algorithm on outcomes following major gastrointestinal surgery: a randomized clinical trial and systematic review. JAMA. 2014 Jun 4;311(21):2181-90. doi: 10.1001/jama.2014.5305.

    PMID: 24842135BACKGROUND

MeSH Terms

Interventions

Plasmalyte A

Study Officials

  • Amélie Delaporte, MD

    CHU Brugmann

    PRINCIPAL INVESTIGATOR

  • Alexandre Joosten, MD

    Erasme

    PRINCIPAL INVESTIGATOR

  • Philippe Van der Linden, MD, Pr

    CHU Brugmann

    PRINCIPAL INVESTIGATOR

  • Brigitte Ickx, Md, Pr

    Erasme

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of clinic

Study Record Dates

First Submitted

December 5, 2014

First Posted

December 9, 2014

Study Start

February 24, 2015

Primary Completion

December 21, 2017

Study Completion

December 21, 2017

Last Updated

January 19, 2018

Record last verified: 2018-01

Locations

BE(2)