E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients undergoing surgery for pancreatic, gastric or esophageal cancer. |
Patienter til kirurgi for pankreas-, ventrikel- eller øsofaguscancer. |
|
E.1.1.1 | Medical condition in easily understood language |
Patients undergoing surgery for pancreatic, gastric or esophageal cancer. |
Patienter til kirurgi for kræft i bugspytkirtel, mavesæk eller spiserør. |
|
E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10068093 |
E.1.2 | Term | Gastrointestinal surgery |
E.1.2 | System Organ Class | 10042613 - Surgical and medical procedures |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10011508 |
E.1.2 | Term | Crystalloid colloid fluid replacement |
E.1.2 | System Organ Class | 10042613 - Surgical and medical procedures |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To investigate differences in intraoperative global and local oxygen delivery in goal directed haemodynamic optimisation with crystalloids versus colloids. |
At undersøge forskelle i intraoperativ systemisk og lokal (mesenteriel) iltleverance (DO2 og
mDO2) som følge af GDT baseret på bolus kolloid versus bolus krystalloid. |
|
E.2.2 | Secondary objectives of the trial |
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. |
At undersøge eventuelle forskelle mellem disse to metoder i forhold til i intraoperativ
hæmodynamisk stabilitet, postoperativ væskebalance, vægt, forekomst af væskerelaterede
komplikationer og indlæggelsestid på intensiv og sygehus indtil 30 dage efter operationen. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
All patients eligible for relevant surgery.
Age > 18 years.
Informed concent. |
Alle patienter til relevant kirurgi.
Alder > 18 år.
Informeret samtykke. |
|
E.4 | Principal 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. |
Præoperativ nyreinsufficiens (eGFR < 30 eller hæmodialyse), præoperativ lithiumbehandling, kropvægt < 40 kg, anden hjerterytme end sinusrytme, aortaklap-insufficiens, svært hjertesvigt med hypervolæmi, hovedtraume, overfølsomhed over for albumin.
Patienter med cancer pancreatis som har modtaget downstaging i form af kemo-strålebehandling forud for resektion, non-resektabel tumor.
Patientens afslag til deltagelse i projektet. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Changes in intraoperative global and local (mesenterial) oxygen delivery (DO2 og mDO2). |
Tidsmæssig ændring i intraoperativ systemisk og lokal (mesenteriel) iltleverance (DO2 og mDO2). |
|
E.5.1.1 | 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
|
T0 – Baseline, umiddelbart efter induktion af generel anæstesi.
T1 – Knivtid start (laparoskopisk ultralyd)
T2 – Åben abdominal kirurgi start
T3 – Abdominale præparat ude
T4 – Abdominal kirurgisk lukning
|
|
E.5.2 | 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 |
1.
Cardiac index (l/min/m2)
Slagvolumen (ml/min)
Systemisk perifer modstand (dynes · s · cm-5)
Pulstryk-variation (%)
Oxygen delivery (ml/min)
Middel-arterietryk (mmHg)
Puls (slag/min)
Centralt venetryk (mmHg)
Inotropi (μg/kg/min)
2.
Vægt
Væskebalance
3.
Væskerelaterede komplikationer |
|
E.5.2.1 | 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. |
1.
T0 – Baseline, umiddelbart efter induktion af generel anæstesi.
T1 – Knivtid start (laparoskopisk ultralyd)
T2 – Åben abdominal kirurgi start
T3 – Abdominale præparat ude
T4 – Abdominal kirurgisk lukning
T5 - knivtid slut
2.
Operationsdagens morgen.
Morgen, postoperative dag 1, 2, 3
Desuden også væskebalance postoperativt.
3. 30 dage postoperativt. |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
1 year after inclusion of patient number 1, or after including patient number 60, whichever comes first. |
1 år efter inklusion af patient nummer 1, eller efter inklusion af patient nummer 60, afhængigt af, hvad der kommer først. |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |