IMpact of Phenylephrine vs. norAdrenaline on systemic hemodynamics and Cerebral Tissue circulation and oxygenation in anesthetized brain tumor patients (IMPACT)

Start 4 Jul 2024 · Status Ongoing, recruiting · 1 EU/EEA countries · 1 sites

Overview

Sponsor-declared trial summary

Phase Phase III and Phase IV (Integrated)

Status Ongoing, recruiting

Participants planned 32

Countries 1

Sites 1

low blood pressure during anesthesia

Key facts

Sponsor: Region Midtjylland
Participant type: Patients
Age range: 18-64 years, 65+ years
Gender: Male and Female
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
Trial duration: 4 Jul 2024 → ongoing
Decision date (initial): 2024-07-04
Transition trial: Yes
Low-intervention: No
Rare-disease indication: No
Vulnerable population: No

External identifiers

EU CT number: 2024-515400-40-00
EudraCT number: 2021-006168-26

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

In the attempt to improve brain outcomes, we initiate this
interdisciplinary and international collaborative project to understand
the impact of two commonly used vasopressor agents (phenylephrine vs.
noradrenaline) on cerebral circulation and oxygenation in patients
undergoing brain tumor resection. We also aim to understand the impact
of vasopressor-induced changes in systemic hemodynamics on regional
perfusion in organs including the brain, heart and muscle.

Conditions and MedDRA coding

low blood pressure during anesthesia

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

Subjects aged 18-75 yr. scheduled for elective craniotomy for supratentorial tumors with a minimum size of 3 cm (measured as the largest diameter in any plane) are included

Exclusion criteria 1

Exclusion criteria are history of allergy or intolerance to one of the study medications, an American Society of Anesthesiologists (ASA) physical status IV to VI, pregnancy (positive pregnancy urine test) or breastfeeding and inability to give written informed consent

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

The primary endpoint is the between-group difference in ΔCBF (Δ= posttreatment value-pretreatment value).

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Phenylephrine

SUB09788MIG · Substance

Active substance: Phenylephrine
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: INTRAVENOUS
Max daily dose: 100 mg milligram(s)
Max total dose: 100 mg milligram(s)
Max treatment duration: 1 Day(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Noradrenaline Tartrate

SUB03455MIG · Substance

Active substance: Noradrenaline Tartrate
Pharmaceutical form: SOLUTION FOR INFUSION
Route of administration: INTRAVENOUS
Max daily dose: 100 mg milligram(s)
Max total dose: 100 mg milligram(s)
Max treatment duration: 1 Day(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Region Midtjylland

Sponsor organisation: Region Midtjylland
Address: Palle Juul-Jensens Boulevard 99
City: Aarhus N
Postcode: 8200
Country: Denmark

Scientific contact point

Organisation: Region Midtjylland
Contact name: Mads Rasmussen

Public contact point

Organisation: Region Midtjylland
Contact name: Mads Rasmussen

Third parties 1

Organisation	City, country	Duties
Aarhus Universitet ORG-100028380	Aarhus N, Denmark	On site monitoring

Locations

1 EU/EEA country · 1 investigational sites

By country

Country	MS status	Planned subjects	Sites
Denmark	Ongoing, recruiting	32	1
Rest of world	—	0	—

Investigational sites

Denmark

1 site · Ongoing, recruiting

Region Midtjylland

Anesthesiology, Palle Juul-Jensens Boulevard 99, 8200, Aarhus N

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country	Trial start	Trial end	Recruitment start	Recruitment end	Early termination
Denmark	2024-07-04		2024-07-04

Oversight and notifications

Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77

Serious breaches 1 · Art. 52 CTR

Serious breach SB-57522

Sponsor became aware: 2024-11-04
Date of breach: 2024-11-04
Submission date: 2024-11-14
Member states concerned: Denmark
Categories: Protocol
Areas impacted: Other
Benefit-risk balance changed: Yes
Description: During the placement of a urinary catheter for a patient participating in the PhD project (IMPACT), an unintended injury occurred in the patient’s urinary tract, resulting in a “false passage” (via falsa). This complication required the placement of a suprapubic catheter by our urological colleagues to ensure proper drainage and prevent further complications.

Following the incident, the patient was thoroughly informed about the event and the remedial actions taken. We have provided the information directly to the patient, explaining the nature of the injury and the steps being taken to manage it. Additionally, the patient was advised about the option to seek compensation for the injury sustained. The urology team has implemented a treatment and follow-up plan to support optimal healing and recovery.

We have also arranged for the patient to have direct contact with us if any further questions or concerns arise. Thus, all aspects of patient care and follow-up have been managed with the patient’s safety and well-being as the highest priority.
Sponsor actions: To prevent similar incidents in the future and to enhance patient safety, we have decided to implement the following adjustments in the project protocol:

1. Revised Inclusion Criteria:
Going forward, we will only include patients who are scheduled to receive a catheter placement as part of their planned treatment (e.g., patients undergoing tumor resections with the estimated operation time exceeding 1,5-2 hours) and will exclude those undergoing minor procedures, such as biopsies, where catheter placement is not inherently required.

2. Enhanced Monitoring of Catheters:
We have introduced a routine for checking both intravenous and urinary catheters between each PET session. This will be documented on a simple checklist or directly in the anesthesia log to ensure systematic follow-up and reduce the risk of further complications.

3. No Change to Patient Information:
Since the revised inclusion criteria do not introduce any new procedures beyond those that patients are already expected to undergo as part of their treatment, we believe that no updates to the current patient information are necessary.

These adjustments have been implemented to improve the safety of the project’s intervention procedures without altering the patients’ original treatment plans. The actions will be implemented by the next patient inclusion.

Organisation	City	Country	Type
Aarhus University Hospital	Aarhus N	Denmark	Clinical facility BE/BA

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 10 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Type	Title	Version
Protocol (for publication)	IMPACT	1
Protocol (for publication)	IMPACT protocol with amendments_19112025_clean version	1
Protocol (for publication)	IMPACT protocol with amendments_19112025_track changes version	1
Recruitment arrangements (for publication)	Recruitment arrangements	1
Subject information and informed consent form (for publication)	Deltagerinformation om deltagelse i et videnskabeligt forsg	1
Subject information and informed consent form (for publication)	Deltagerinformation om deltagelse i et videnskabeligt forsg_19112025_clean version	1
Subject information and informed consent form (for publication)	Deltagerinformation_19112025_track changes version	1
Subject information and informed consent form (for publication)	Samtykke erklring_version 1	1
Summary of Product Characteristics (SmPC) (for publication)	Produktresume fenylefrin	1
Summary of Product Characteristics (SmPC) (for publication)	Produktresume Noradrenalin Macure	1

Application history

2 submissions — initial application plus substantial / non-substantial modifications

#	Type	Code	Submitted	Reference MS	Conclusion	Decision date
1	INITIAL	IN	2024-06-21	Denmark	Acceptable 2024-07-02	2024-07-04
2	NON SUBSTANTIAL MODIFICATION	NSM-1	2025-11-24	Denmark		2025-11-24