Crystalloids or colloids for goal-directed fluid therapy with closed-loop assistance in major surgery?

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-005337-31-BE

Enrollment

160

Registered

2015-01-08

Start date

2015-02-23

Completion date

Unknown

Last updated

2018-01-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Major abdominal surgery, by laporotomy. MedDRA version: 19.0 Level: LLT Classification code 10065498 Term: Infusion site anesthesia System Organ Class: 100000004867

Interventions

Trade Name: Plasmalyte Pharmaceutical Form: Infusion Trade Name: Volulyte Product Name: Volulyte Pharmaceutical Form: Infusion

Eligibility

Sex/Gender

All

Inclusion criteria

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 a general anesthesia and a minimally invasive cardiac output monitoring (Vigileo/Flotrac). • Patients who provide written informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 107 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 53

Exclusion criteria

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 •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.

Design outcomes

Primary

Measure	Time frame
Main Objective: This study will examine whether there is a significant difference in postoperative outcomes between GDFT using a colloid solution versus a crystalloid solution. ;Secondary Objective: Study of the differences between the two groups for the following points: mortality, length of hospitalization, fluid balance, transfusion rate, incidence of hypotension, need of vasopressors and mean cardiac index. Addition of a monitoring of the long term effects (at 6 months and 1 year post surgery) of both fluids (balanced cristalloids and colloids) on hepatic and renal function, occurence of pruritus and patient quality of life. ;Primary end point(s): Difference between the 2 groups in postoperative morbidity identified with the Post-Operative Morbidity Survey (POMS score) on postoperative days 2.;Timepoint(s) of evaluation of this end point: Postoperative day 2.	—

Measure

Time frame

Main Objective: This study will examine whether there is a significant difference in postoperative outcomes between GDFT using a colloid solution versus a crystalloid solution. ;Secondary Objective: Study of the differences between the two groups for the following points: mortality, length of hospitalization, fluid balance, transfusion rate, incidence of hypotension, need of vasopressors and mean cardiac index. Addition of a monitoring of the long term effects (at 6 months and 1 year post surgery) of both fluids (balanced cristalloids and colloids) on hepatic and renal function, occurence of pruritus and patient quality of life. ;Primary end point(s): Difference between the 2 groups in postoperative morbidity identified with the Post-Operative Morbidity Survey (POMS score) on postoperative days 2.;Timepoint(s) of evaluation of this end point: Postoperative day 2.

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Secondary

Measure	Time frame
Secondary end point(s): - Difference in 30-day post-operative mortality between the 2 groups - Difference in duration of hospital length of stay as well as ICU length of stay. - Fluid balance during surgery - Transfusion rate - Incidence of hypotension (defined as total case time spent with 20% drop from baseline preoperative blood pressure). - Need of vasopressors - Mean case cardiac index (L /BSA), Mean case cardiac stroke volume index (mL/ BSA). - Hepatic and renal function: assessed in the blood samples taken according to the standard of care, closest to 6 months and 1 year after surgery. - Prurit apparition: phone call at 6 months and 1 year after surgery. - Patient quality of life: assessed by phone by means of the Whodas scale, 6 months and 1 year after surgery.;Timepoint(s) of evaluation of this end point: Up to one year after the surgery	—

Measure

Time frame

Secondary end point(s): - Difference in 30-day post-operative mortality between the 2 groups - Difference in duration of hospital length of stay as well as ICU length of stay. - Fluid balance during surgery - Transfusion rate - Incidence of hypotension (defined as total case time spent with 20% drop from baseline preoperative blood pressure). - Need of vasopressors - Mean case cardiac index (L /BSA), Mean case cardiac stroke volume index (mL/ BSA). - Hepatic and renal function: assessed in the blood samples taken according to the standard of care, closest to 6 months and 1 year after surgery. - Prurit apparition: phone call at 6 months and 1 year after surgery. - Patient quality of life: assessed by phone by means of the Whodas scale, 6 months and 1 year after surgery.;Timepoint(s) of evaluation of this end point: Up to one year after the surgery

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Countries

Belgium

Contacts

Public ContactService of Anesthesiology

CHU Brugmann

amelie.delaporte@ulb.ac.be32 024773996

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026