Clinical Trials Register

Summary
EudraCT Number:	2021-000861-34
Sponsor's Protocol Code Number:	2021-000861-34
National Competent Authority:	Sweden - MPA
Clinical Trial Type:	EEA CTA
Trial Status:	Trial now transitioned
Date on which this record was first entered in the EudraCT database:	2021-12-15
Trial 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

Sweden - MPA

A.2

EudraCT number

2021-000861-34

A.3

Full title of the trial

Comparison of albumin and Ringer´s solution for optimization of the plasma volume and hemodynamics during surgery.

Jämförelse mellan Albumin och Ringeracetat för optimering av plasmavolym och hemodynamik under kirurgi (En öppen randomiserad fas IV studie)

A.3.1

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

Does a fluid bolus intravenously expand the plasma volume?

Ökar en vätskestöt, som dropp, plasmavolymen i samband med anestesi och operation?

A.3.2

Name or abbreviated title of the trial where available

Fluid challenge and plasma volume

Vätskestöt och plasmavolymen

A.4.1

Sponsor's protocol code number

2021-000861-34

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	Region Ostergotland
B.1.3.4	Country	Sweden
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	Region Ostergotland
B.4.2	Country	Sweden
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Region Ostergotland
B.5.2	Functional name of contact point	Region Ostergotland
B.5.3	Address:
B.5.3.1	Street Address	Universitetssjukhuset
B.5.3.2	Town/ city	Linköping
B.5.3.3	Post code	581 85
B.5.3.4	Country	Sweden
B.5.4	Telephone number	46101030000

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	Alburex 50 g/l
D.2.1.1.2	Name of the Marketing Authorisation holder	CSL Behring
D.2.1.2	Country which granted the Marketing Authorisation	Sweden
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.3.1	Product name	Human albumin
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	Albumin
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	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	50
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	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.IMP: 2
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	Alburex 200g/l
D.2.1.1.2	Name of the Marketing Authorisation holder	CSL Behring
D.2.1.2	Country which granted the Marketing Authorisation	Sweden
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.3.1	Product name	Human albumin
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	Albumin
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	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	200
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: 3
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	Ringer-acetat Fresenius Kabi
D.2.1.1.2	Name of the Marketing Authorisation holder	Fresenius Kabi
D.2.1.2	Country which granted the Marketing Authorisation	Sweden
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.3.1	Product name	Ringer-acetat
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	Sodiumchloride
D.3.9.3	Other descriptive name	RINGER'S ACETATE SOLUTION
D.3.9.4	EV Substance Code	SUB190935
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	5.9
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Sodium acetate trihydrate
D.3.9.3	Other descriptive name	SODIUM ACETATE TRIHYDRATE
D.3.9.4	EV Substance Code	SUB15266MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	4.1
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Potassium chloride
D.3.9.3	Other descriptive name	Potassium chloride
D.3.9.4	EV Substance Code	SUB12559MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	0.3
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Magnesiumkloridhexahydrat
D.3.9.3	Other descriptive name	MAGNESIUM CHLORIDE HEXAHYDRATE
D.3.9.4	EV Substance Code	SUB12526MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	0.2
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 in need of major laparoscopic surgery in the abdomen, lasting longer than 90 minutes

Patienter med behov av större laparoskopisk kirurgi i bukhålan, som varar mer än 90 minuter.

E.1.1.1

Medical condition in easily understood language

Patients in need of major laparoscopic surgery in abdomen, lasting longer than 90 minutes.

Patienter med behov av större laparoskopisk kirurgi i bukhålan, som varar mer än 90 minuter.

E.1.1.2

Therapeutic area

Body processes [G] - Physiological processes [G07]

MedDRA Classification

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

Does a fluid challenge give an increase in plasmavolume, measured as a dilution of the red blood cells, during bariatric surgery?
Does acetated Ringers give a similar plasmavolume increase as albumin solutions both in size and in length?

Ger en ”fluid challenge” en ökning av plasmavolymen, mätt som utspädning av de röda blodkropparna, vid laparoskopisk kirurgi?
Ger Ringeracetat en likvärdig plasmavolymsökning vad gäller storlek och duration som albuminlösningar?

E.2.2

Secondary objectives of the trial

Is there a correlation between volume effect and circulatory effects, such as blood pressure and cardiac output?
Does "fluid challenge" with acetated Ringers resilt in a clinical relevant effect (plasma volume and cardiac output) on the longer run?
In the perspective of 24 hours, does the choise of fluid have any importance for the fluid balance of the body?
How are kidney function markers and arterial blood gases influenced by the three different fluid therapies?

Korrelerar plasmavolymsförändringar med cirkulationsfysiologiska parametrar?
Har ”fluid challenge” med Ringer-acetat någon klinisk relevant effekt (plasmavolym och hjärtminutvolym) på lite längre sikt?
Kan man uppnå likvärdig effekt med mindre volym, dvs hyperonkotiskt albumin?
Har det på ett dygns perspektiv någon betydelse, för kroppens vätskebalans, vilken vätska som används för volymsbelastning?
Hur påverkas njurfunktions markörer och blodgaser av de tre olika terapierna?

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Subject scheduled for major laparoscopic bowel surgery lasting 90 minutes or more.
Research subject giving written approval
Non-pregnant female subject adequate contraceptive, negative pregnancy test or menopausal/without bleeding the last year)
Subjects belonging to ASA-classifications I to III
18 to 80 years of age.

Forskningspersonen har gett sitt skriftliga samtycke till att delta i studien.
För kvinnliga deltagare i fertil ålder ska adekvat preventivmedel användas, t.ex. P-piller, spiral eller P-stav eller ett negativt graviditetstest. För postmenopausala kvinnor gäller ingen mens på 12 månader för att frångå kravet på effektiv preventivmedel.
Deltagare ska tillhöra ASA (American Society of Anesthesiology) klassificering I till III.
Planerad större laparoskopisk bukkirurgi, som planeras vara i 90 minuter eller mer.
18 till 80 års ålder

E.4

Principal exclusion criteria

Patient with known congestive heart failure
<18 years or >80 years of age
Known allergic reaction to albumin
Pronounced Kidney failure
Pregnancy, breast feeding or planned pregnancy
Mental incapability, sight or language problems, influencing the capability to understand the implications of participating in the study.
Recent paticipation in a clinical trial the last 30 days. Earlier participation in the current study.

Patienter med känd hjärtsvikt
<18 år eller >80 år
Känd eller misstänkt allergi mot albumin
Uttalad njursvikt
Graviditet, amning eller planerad graviditet.
Mental oförmåga, läs, syn eller språksvårigheter som medför svårighet att förstå innebörden av att delta i studien
Deltar eller nyligen deltagit eller i en klinisk läkemedelsprövning, de senaste 30 dagarna. Tidigare deltagande i denna studie.

E.5 End points

E.5.1

Primary end point(s)

Decrease of hemoglobine concentration when a fluid challenge is adminstered. The decrease is processed mathematically in a kinetic model.

Hemoglobinsänkning i samband med vätskebolus, vilken bearbetas matematiskt i en kinetisk modell.

E.5.1.1

Timepoint(s) of evaluation of this end point

Before, during and up to 60 minutes after the fluid challenge.
Timepoints to be statiscaly evaluated are before and after the infusion as well as 30 minutes after end of the infusion.

Före, under och up till 60 minuter efter en vätskestöt. Tidpunkter som kommer att ingå i en statistisk bearbetning är före och efter infusionen samt 30 minuter efter infusionsavslut.

E.5.2

Secondary end point(s)

Changes in cardiac output, blood pressure and pulse as well as measurements in plasma of albumine and kreatinin.
Fluidcomposition and balance preoperative and one day after surgery.

Cirkulationsfysiologiska mätningar. Förändring i P-albumin, P-Kreatinin, Vätskesammansättning och vätskebalans preoperativt och efter ett dygn.

E.5.2.1

Timepoint(s) of evaluation of this end point

Preoperative, after surgery and at the first postoperative day

Före operationen, efter kirurgi och första dagen efter operationen.

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

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

Yes

E.6.8

Bioequivalence

E.6.9

Dose response

Yes

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

E.8.1.1

Randomised

Yes

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

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)

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

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in 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

Yes

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

Last study of the last subject.

Sista studietillfället på den sista deltagaren.

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

Yes

F.3.3.1

Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2021-12-15.

Yes

F.3.3.2

Women of child-bearing potential using contraception

Yes

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

2022-01-28

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2022-07-01

P. End of Trial
P.	End of Trial Status	Trial now transitioned

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