Individualised perioperative blood pressure and fluid therapy in oe-sophagectomy - Study protocol for a prospective randomised controlled trial

Individualised perioperative blood pressure and fluid therapy in oesophagectomy - Study protocol for a prospective randomised controlled trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-002816-30-DK

Enrollment

100

Registered

2021-09-03

Start date

2021-11-12

Completion date

Unknown

Last updated

2024-12-09

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

Conditions

Oesophagectomy MedDRA version: 20.0 Level: PT Classification code 10030215 Term: Oesophagectomy System Organ Class: 10042613 - Surgical and medical procedures

Interventions

Trade Name: Noradrenalin SAD Product Name: Noradrenalin SAD Product Code: C01CA03 Pharmaceutical Form: Infusion INN or Proposed INN: Noradrenaline SAD Other descriptive name: NORADRENALINE HYDROCHLORI

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Scheduled for elective esophagectomy at the Department of Thoracic Surgery, Aarhus University Hospital, comprising of: o Esophagectomy with gastric pull-up o Distal esophagectomy with total gastrectomy and other reconstructive procedure (duodenum eller colon) o Total esophagectomy med colonanastomosis in the neck area • Age = 18 years • Scheduled for laparoscopy (and not open surgery) (study II only) 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 70 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30

Exclusion criteria

Exclusion criteria: • Lack of consent • Women of childbearing age without negative pregnancy test • Known allergy or intolerance to any of the included drugs • Cardiac pacemaker • Chronic- or paroxysmal atrial fibrillation • Left ventricular ejection fraction <40% (if known) • Right ventricular TAPSE < 16mm (if known) • Cardiac pacemaker • Chronic- or paroxysmal atrial fibrillation • Left ventricular ejection fraction <40% (if known) • Right ventricular TAPSE < 16mm (if known)

Design outcomes

Primary

Measure	Time frame
Main Objective: Version 2.1 Date: 03.06.22 To investigate the impact of goal directed fluid therapy (GDT) vs. standard fluid/vasoactive therapy in the perioperative phase of oesophagectomy on comprehensive complication index at 30 days;Secondary Objective: For all secondary endpoints see E.5.2 Secondary end point(s). ;Primary end point(s): Version 2.1 Date: 03.06.22 The primary endpoint is overall morbidity using the CCI calculated from www.assessurgery.com ;Timepoint(s) of evaluation of this end point: Day 30 post-operative	—

Measure

Time frame

Main Objective: Version 2.1 Date: 03.06.22 To investigate the impact of goal directed fluid therapy (GDT) vs. standard fluid/vasoactive therapy in the perioperative phase of oesophagectomy on comprehensive complication index at 30 days;Secondary Objective: For all secondary endpoints see E.5.2 Secondary end point(s). ;Primary end point(s): Version 2.1 Date: 03.06.22 The primary endpoint is overall morbidity using the CCI calculated from www.assessurgery.com ;Timepoint(s) of evaluation of this end point: Day 30 post-operative

—

Secondary

Measure	Time frame
Secondary end point(s): Within anaesthesia time - Anaesthetics used - Vasoactive medication - Systemic blood pressure (systolic- and diastolic blood pressure every 20 minutes – mmHg) - Fluids: colloids (mL), crystalloids (mL) - Estimated blood loss (mL) - Blood transfusion (type and mL) - Urine output (mL) - Net fluid balance from the start of anaesthesia until the end of anaesthesia (mL) - Net fluid balance from the start of anaesthesia until 24 hours after start of anaesthesia - One-lung ventilation time and volume (mins and mL) - Laparoscopic inflation time (no & min) - Open thorax (open surgery only) (no & min) - Thoracoscopic surgery time (only scopic surgery in thorax) (no & min) o CO (continuous – L/min) o SVV (continuous - %) o PPV (continuous - %) o HPI (continuous – 1-100) o Mean, systolic and diastolic blood pressures (continuous – mmHg) - Timing of surgeon’s hands-on that may influence dynamic haemodynamic variables - Peritoneal pressure (from the laparoscopy inflation device) is recorded manually during surgery In the ICU - Opioids used (morphine (mg), fentanyl (ug), alfentanil (mg), oxycodone (mg). - Epidural dose of. Breivik’s mixture25 (bupivacaine 0.1 mg/mL, fentanyl 2 ug/mL, adrenaline 2 ug/mL) mL - Systemic blood pressure (systolic- and diastolic blood pressure every 20 minutes – mmHg) o CO (continuous – L/min) o PPV (continuous - %) o HPI (continuous – 1-100) o Mean, systolic and diastolic blood pressures (continuous – mmHg) - Colloids (mL) - Crystalloids (mL) - Sum of colloids & crystalloids (mL) - Blood transfusion (type and mL) - Urine output (mL) - New onset arrhythmia (atrial fibrillation/atrial flutter (no), ventricular tachycardia (no) - Troponin I (day 1 morning) Ultrasonographic muscle mass assessment which will be compared to CCI at 30 and 90 days. ? Quadriceps depth (cm) day 1 and 90 ? Rectus femoris cross sectional area (cm2) day 1 and 90 Variables from preoperative CT-scans o Average of left and right psoas muscle area at the le	—

Measure

Time frame

Secondary end point(s): Within anaesthesia time - Anaesthetics used - Vasoactive medication - Systemic blood pressure (systolic- and diastolic blood pressure every 20 minutes – mmHg) - Fluids: colloids (mL), crystalloids (mL) - Estimated blood loss (mL) - Blood transfusion (type and mL) - Urine output (mL) - Net fluid balance from the start of anaesthesia until the end of anaesthesia (mL) - Net fluid balance from the start of anaesthesia until 24 hours after start of anaesthesia - One-lung ventilation time and volume (mins and mL) - Laparoscopic inflation time (no & min) - Open thorax (open surgery only) (no & min) - Thoracoscopic surgery time (only scopic surgery in thorax) (no & min) o CO (continuous – L/min) o SVV (continuous - %) o PPV (continuous - %) o HPI (continuous – 1-100) o Mean, systolic and diastolic blood pressures (continuous – mmHg) - Timing of surgeon’s hands-on that may influence dynamic haemodynamic variables - Peritoneal pressure (from the laparoscopy inflation device) is recorded manually during surgery In the ICU - Opioids used (morphine (mg), fentanyl (ug), alfentanil (mg), oxycodone (mg). - Epidural dose of. Breivik’s mixture25 (bupivacaine 0.1 mg/mL, fentanyl 2 ug/mL, adrenaline 2 ug/mL) mL - Systemic blood pressure (systolic- and diastolic blood pressure every 20 minutes – mmHg) o CO (continuous – L/min) o PPV (continuous - %) o HPI (continuous – 1-100) o Mean, systolic and diastolic blood pressures (continuous – mmHg) - Colloids (mL) - Crystalloids (mL) - Sum of colloids & crystalloids (mL) - Blood transfusion (type and mL) - Urine output (mL) - New onset arrhythmia (atrial fibrillation/atrial flutter (no), ventricular tachycardia (no) - Troponin I (day 1 morning) Ultrasonographic muscle mass assessment which will be compared to CCI at 30 and 90 days. ? Quadriceps depth (cm) day 1 and 90 ? Rectus femoris cross sectional area (cm2) day 1 and 90 Variables from preoperative CT-scans o Average of left and right psoas muscle area at the le

—

Countries

Denmark

Contacts

Public ContactDepartment of Anaesthesiology

Department of Anaesthesiology, Aarhus University Hospital

peter.juhl-olsen@clin.au.dk

Outcome results

None listed

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