Crystalloid versus colloid for goal directed circulatory optimisation in major abdominal cancer surgery.

Crystalloid versus colloid for goal directed haemodynamic optimisation in major abdominal cancer surgery.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-002217-36-DK

Enrollment

Registered

2013-06-25

Start date

2013-07-04

Completion date

Unknown

Last updated

2018-11-06

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

Conditions

Patients undergoing surgery for pancreatic, gastric or esophageal cancer. MedDRA version: 20.0 Level: PT Classification code 10068093 Term: Gastrointestinal surgery System Organ Class: 10042613 - Surgical and medical procedures MedDRA version: 20.0 Level: LLT Classification code 10011508 Term: Crystalloid colloid fluid replacement System Organ Class: 10042613 - Surgical and medical procedures

Interventions

Trade Name: Human Albumin ”CSL Behring”, 5 % Pharmaceutical Form: Solution for infusion INN or Proposed INN: Human Albumin CAS Number: 7024-90-7 Other descriptive name: HUMAN ALBUMIN SOLUTION Concentr

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: All patients eligible for relevant surgery. Age > 18 years. Informed concent. 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 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 40

Exclusion criteria

Exclusion criteria: Preoperative renal failure (eGFR < 30 or renal replacement therapy), lithium treatment, body weight < 40 kg, not sinus-rythtm, aortic valve regurgitation, severe haert failure with hypervolemia, traumatic brain injury, known allergic reactions to albumin. Patients with pancreatic cancer, who have been down-staged using chemotherapy and/or radiation therapy. Patients with on-resectable tumor. Patients declining informed concent.

Design outcomes

Primary

Measure	Time frame
Main Objective: To investigate differences in intraoperative global and local oxygen delivery in goal directed haemodynamic optimisation with crystalloids versus colloids.;Secondary Objective: To investigate potential differences between the abovementioned therapeutics with regard to intraoperative haemodanamic stability, fluid balance, body weight, fluid related complications, and length of stay in ICU and hospital for 30 days postoperatively.;Primary end point(s): Changes in intraoperative global and local (mesenterial) oxygen delivery (DO2 og mDO2).;Timepoint(s) of evaluation of this end point: T0 – Baseline, immediately after induction of general anaesthesia. T1 – Surgery start (laparoscopic ultrasound) T2 – Open abdominal surgery start T3 – Abdominal preparation out T4 – Abdominal closure	—

Measure

Time frame

Main Objective: To investigate differences in intraoperative global and local oxygen delivery in goal directed haemodynamic optimisation with crystalloids versus colloids.;Secondary Objective: To investigate potential differences between the abovementioned therapeutics with regard to intraoperative haemodanamic stability, fluid balance, body weight, fluid related complications, and length of stay in ICU and hospital for 30 days postoperatively.;Primary end point(s): Changes in intraoperative global and local (mesenterial) oxygen delivery (DO2 og mDO2).;Timepoint(s) of evaluation of this end point: T0 – Baseline, immediately after induction of general anaesthesia. T1 – Surgery start (laparoscopic ultrasound) T2 – Open abdominal surgery start T3 – Abdominal preparation out T4 – Abdominal closure

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Secondary

Measure	Time frame
Secondary end point(s): 1. Cardiac index (l/min/m2) Stroke volume (ml/min) Systemic vascular resistance (dynes · s · cm-5) Pulse pressure variation (%) Oxygen delivery (ml/min) Mean arterial pressure (mmHg) Heart rate (beats/min) Central venous pressure (mmHg) Inotropics (µg/kg/min) 2. Body weight Fluid balance 3. Fluid related complications;Timepoint(s) of evaluation of this end point: 1. T0 – Baseline, immediately after induction of general anaesthesia. T1 – Surgery start (laparoscopic ultrasound) T2 – Open abdominal surgery start T3 – Abdominal preparation out T4 – Abdominal closure T5 - Surgery end 2. Morning, day of surgery Morning, postoperative day 1, 2, 3 Fluidbalance also after surgery. 3. 30 days postoperative.	—

Measure

Time frame

Secondary end point(s): 1. Cardiac index (l/min/m2) Stroke volume (ml/min) Systemic vascular resistance (dynes · s · cm-5) Pulse pressure variation (%) Oxygen delivery (ml/min) Mean arterial pressure (mmHg) Heart rate (beats/min) Central venous pressure (mmHg) Inotropics (µg/kg/min) 2. Body weight Fluid balance 3. Fluid related complications;Timepoint(s) of evaluation of this end point: 1. T0 – Baseline, immediately after induction of general anaesthesia. T1 – Surgery start (laparoscopic ultrasound) T2 – Open abdominal surgery start T3 – Abdominal preparation out T4 – Abdominal closure T5 - Surgery end 2. Morning, day of surgery Morning, postoperative day 1, 2, 3 Fluidbalance also after surgery. 3. 30 days postoperative.

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Countries

Denmark

Contacts

Public ContactDept. Anaesthesiology V

Odense University Hospital

jannie.bisgaard.staehr@rsyd.dk004560630890

Outcome results

None listed

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