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

Phase 1

• Conditions: Patients undergoing surgery for pancreatic, gastric or esophageal cancer.; MedDRA version: 20.0Level: LLTClassification code 10011508Term: Crystalloid colloid fluid replacementSystem Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]; MedDRA version: 20.0Level: PTClassification code 10068093Term: Gastrointestinal surgerySystem Organ Class: 10042613 - Surgical and medical procedures

• Registration Number: EUCTR2013-002217-36-DK
• Lead Sponsor: Dept. of Anaesthesiology, Odense University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06-25
• Last Update Posted: 6 November 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 60

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.<br>T1 – Surgery start (laparoscopic ultrasound)<br>T2 – Open abdominal surgery start<br>T3 – Abdominal preparation out<br>T4 – Abdominal closure<br>

Secondary Outcome Measures

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