Clinical Trials Register

Summary
EudraCT Number:	2013-002217-36
Sponsor's Protocol Code Number:	20130021
National Competent Authority:	Denmark - DHMA
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2013-06-25
Trial results	View results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Denmark - DHMA

A.2

EudraCT number

2013-002217-36

A.3

Full title of the trial

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

Krystalloid versus kolloid til målrettet hæmodynamisk optimering
ved større abdominal cancerkirurgi.

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

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

Krystalloid versus kolloid til målrettet kredsløbs-optimering
ved større mave-tarm-kirurgi for kræft.

A.4.1

Sponsor's protocol code number

20130021

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Dept. of Anaesthesiology, Odense University Hospital
B.1.3.4	Country	Denmark
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Dept. of Anaesthesiology V, Odense University Hospital
B.4.2	Country	Denmark
B.4.1	Name of organisation providing support	Dept. of Abdominal Surgery A, Odense University Hospital
B.4.2	Country	Denmark
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Odense University Hospital
B.5.2	Functional name of contact point	Dept. Anaesthesiology V
B.5.3	Address:
B.5.3.1	Street Address	Sdr. Boulevard
B.5.3.2	Town/ city	Odense
B.5.3.4	Country	Denmark
B.5.4	Telephone number	004560630890
B.5.6	E-mail	jannie.bisgaard.staehr@rsyd.dk

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Human Albumin ”CSL Behring”, 5 %
D.2.1.1.2	Name of the Marketing Authorisation holder	CSL Behring GmbH
D.2.1.2	Country which granted the Marketing Authorisation	Germany
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.4	Pharmaceutical form	Solution for infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Human Albumin
D.3.9.1	CAS number	7024-90-7
D.3.9.3	Other descriptive name	HUMAN ALBUMIN SOLUTION
D.3.9.4	EV Substance Code	SUB12026MIG
D.3.10	Strength
D.3.10.1	Concentration unit	% (W/V) percent weight/volume
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	5
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	Yes
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 2
D.1.2 and D.1.3	IMP Role	Comparator
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Ringerfundin
D.2.1.1.2	Name of the Marketing Authorisation holder	B. Braun Melsungen AG
D.2.1.2	Country which granted the Marketing Authorisation	Germany
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.4	Pharmaceutical form	Solution for infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Ringerfundin
D.3.9.1	CAS number	8026-10-6
D.3.9.2	Current sponsor code	20130021
D.3.9.3	Other descriptive name	RINGER'S SOLUTION
D.3.9.4	EV Substance Code	SUB33359
D.3.10	Strength
D.3.10.1	Concentration unit	mmol/l millimole(s)/litre
D.3.10.2	Concentration type	equal
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo

E. General Information on the Trial

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

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

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

E.6.2

Prophylaxis

E.6.3

Therapy

Yes

E.6.4

Safety

E.6.5

Efficacy

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

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

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

Yes

E.8.2.2

Placebo

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

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

E.8.5

The trial involves multiple Member States

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.7

Trial has a data monitoring committee

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

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

None.

Ingen.

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2013-06-25

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2013-07-04

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2015-06-30

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