Risk FactorsACUTENCT05195697
ACUTE-Acute Surgical Care- Risk Factors and Outcomes for Patients in Need of Acute Surgical Care
An observational study of Risk Factors and Complication of Surgical Procedure, run by Region Skane at 1 site in Sweden.
Trial summary
Observational retrospective study of patients in need of acute surgical care admitted to Skåne University Hospital between 2009 and 2019. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Risk Factors, Complication of Surgical Procedure, Complication of Treatment
- What is being tested?
- Observational study of different treatments and time to treatment
- How many people
- 3,000 participants
- Where
- 1 siteSweden
- Study dates
- 1 Jan 2020to Dec 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: All patients admitted to to Skåne University hospital in need of acute surgical care between 2009-2019
Who may be able to join
None listed.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Skåne University Hospital
Malmö, Skåne County, 20502
Sara Regnér, PhD, 040 331000, sara.regner@med.lu.se
Jenny Eckner, PhD, 040 331000, Jenny.Eckner@skane.se
About this study
Observational retrospective study of patients in need of acute surgical care admitted to Skåne University Hospital between 2009 and 2019.
Read the detailed description
At Skåne University Hospital approximately 6000 individuals are treated for acute abdominal diseases each year. Given the high number of patients, there is an urgent need to optimize acute surgical care. Lower complication rates would decrease hospital stay, health care costs as well as personal suffering.
Assessment instruments for risks and frailty are not validated for the acute setting and the investigators hypothesize there is room for improvement in prophylactic interventions and risk assessment. The investigators will study cohorts of patients with three different surgical diagnosis: acute pancreatitis, gastrointestinal bleeding and perforated ulcer aiming to identify risk factors for complications or death and to investigate assessment tools in this population. Using propensity score analysis, the investigators will try to identify treatment options associated with better outcome for subcohorts defined by frailty, comorbidity, age or gender. Specific factors of interest include: time to- and kind of treatment, handling of ongoing pharmacological therapy (anticoagulants, corticosteroids) and need for further treatments on a long time basis. The results from this project will be used in a future prospective study where prophylactic treatments and specific treatment options are studied.
- Conditions
- Risk Factors, Complication of Surgical Procedure, Complication of Treatment, Complication of Anesthesia, Long Term Effects After Emergency Surgery, Long Term Effects After GI Bleeding
- Being tested
- Observational study of different treatments and time to treatment
- Keywords
- Emergency surgery, Acute surgery, Complications, Risk factors, Frailty, Ageing
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational study of different treatments and time to treatmentOther
Different treatment based on the clinical decision
| Study group | Role | What they receive |
|---|---|---|
| Mild acute pancreatitis | Patients treated with mild acute pancreatitis during the study period Receives: Other: Observational study of different treatments and time to treatment | |
| Moderate acute pancreatitis | Patients treated with moderate acute pancreatitis during the study period Receives: Other: Observational study of different treatments and time to treatment | |
| Severe acute pancreatitis | Patients treated with severe acute pancreatitis during the study period Receives: Other: Observational study of different treatments and time to treatment | |
| Acute gastrointestinal bleeding | Patients treated with acute gastrointestinal bleeding during the study period Receives: Other: Observational study of different treatments and time to treatment | |
| Perforated ulcer | Patients treated with perforated ulcer during the study period Receives: Other: Observational study of different treatments and time to treatment | |
| Older than 70 years | Patients older than 70 years Receives: Other: Observational study of different treatments and time to treatment | |
| Less than 70 years | Patients younger than 70 years Receives: Other: Observational study of different treatments and time to treatment | |
| Prothrombotic medications | Patients on prothrombotic medications Receives: Other: Observational study of different treatments and time to treatment | |
| Frail patients | Patients with increased frailty score Receives: Other: Observational study of different treatments and time to treatment | |
| Reintervention group | Patients in need of reintervention Receives: Other: Observational study of different treatments and time to treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Defined by Swedish registers
Measured: 5 years
Reintervention
Defined by medical records
Measured: 5 years
Recurrent disease
Defined by medical records
Measured: 5 years
Secondary outcomes (3)
Lengths of hospital stay
defined by medical records
Measured: 5 years
Number of interventions
defined by medical records
Measured: 5 years
complications
defined by medical records and Swedish Registers
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2022
- Study start1 Jan 2020
- Primary completionDec 2028 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Risk FactorsStudies of the same condition, open and under way.
- More trials run by Region SkaneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Collaborators
- Lund University
- Responsible party
- Sponsor
- Investigators
- Sara Regnér, PhD, Principal investigator, Region Skane
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05195697
- Sponsor's protocol ID
- 2019-03583
- Other IDs
- 2019
- Acronym
- ACUTE
- Status last verified
- Jun 2026
- First submitted
- 4 Jan 2022
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD will be shared after publication of studies from this trial upon request from publishers or other researchers. Only coded data will be shared and all sharing will be done according to the GDPR regulations.
Publications
Forsberg-Puckett A, Wurm Johansson G, Regner S. Presentation of gastrointestinal bleeding in patients with antithrombotic therapy, results from a consecutive retrospective cohort. Scand J Trauma Resusc Emerg Med. 2025 Sep 10;33(1):146. doi: 10.1186/s13049-025-01431-1.
PubMed 40931336
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ACUTE-Acute Surgical Care- Risk Factors and Outcomes for Patients in Need of Acute Surgical Care
- ClinicalTrials.gov ID
- NCT05195697
- Acronym / sponsor ID
- ACUTE / 2019-03583
- Conditions
- Risk Factors, Complication of Surgical Procedure, Complication of Treatment, Complication of Anesthesia, Long Term Effects After Emergency Surgery, Long Term Effects After GI Bleeding
- Keywords
- Emergency surgery, Acute surgery, Complications, Risk factors, Frailty, Ageing
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Collaborators
- Lund University
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 19 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Observational retrospective study of patients in need of acute surgical care admitted to Skåne University Hospital between 2009 and 2019.
Detailed description
At Skåne University Hospital approximately 6000 individuals are treated for acute abdominal diseases each year. Given the high number of patients, there is an urgent need to optimize acute surgical care. Lower complication rates would decrease hospital stay, health care costs as well as personal suffering.
Assessment instruments for risks and frailty are not validated for the acute setting and the investigators hypothesize there is room for improvement in prophylactic interventions and risk assessment. The investigators will study cohorts of patients with three different surgical diagnosis: acute pancreatitis, gastrointestinal bleeding and perforated ulcer aiming to identify risk factors for complications or death and to investigate assessment tools in this population. Using propensity score analysis, the investigators will try to identify treatment options associated with better outcome for subcohorts defined by frailty, comorbidity, age or gender. Specific factors of interest include: time to- and kind of treatment, handling of ongoing pharmacological therapy (anticoagulants, corticosteroids) and need for further treatments on a long time basis. The results from this project will be used in a future prospective study where prophylactic treatments and specific treatment options are studied.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| Mild acute pancreatitis | – | Other: Observational study of different treatments and time to treatmentPatients treated with mild acute pancreatitis during the study period |
| Moderate acute pancreatitis | – | Other: Observational study of different treatments and time to treatmentPatients treated with moderate acute pancreatitis during the study period |
| Severe acute pancreatitis | – | Other: Observational study of different treatments and time to treatmentPatients treated with severe acute pancreatitis during the study period |
| Acute gastrointestinal bleeding | – | Other: Observational study of different treatments and time to treatmentPatients treated with acute gastrointestinal bleeding during the study period |
| Perforated ulcer | – | Other: Observational study of different treatments and time to treatmentPatients treated with perforated ulcer during the study period |
| Older than 70 years | – | Other: Observational study of different treatments and time to treatmentPatients older than 70 years |
| Less than 70 years | – | Other: Observational study of different treatments and time to treatmentPatients younger than 70 years |
| Prothrombotic medications | – | Other: Observational study of different treatments and time to treatmentPatients on prothrombotic medications |
| Frail patients | – | Other: Observational study of different treatments and time to treatmentPatients with increased frailty score |
| Reintervention group | – | Other: Observational study of different treatments and time to treatmentPatients in need of reintervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All patients admitted to to Skåne University hospital in need of acute surgical care between 2009-2019
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observational study of different treatments and time to treatmentDifferent treatment based on the clinical decision | Other | Acute gastrointestinal bleeding, Frail patients, Less than 70 years, Mild acute pancreatitis, Moderate acute pancreatitis, Older than 70 years, Perforated ulcer, Prothrombotic medications, Reintervention group, Severe acute pancreatitis |
Primary outcome
Mortality
Time frame: 5 years
Defined by Swedish registers
Reintervention
Time frame: 5 years
Defined by medical records
Recurrent disease
Time frame: 5 years
Defined by medical records
3 secondary outcomes
Lengths of hospital stay
Time frame: 5 years
Number of interventions
Time frame: 5 years
complications
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2026.
- Background: PubMed 40931336Forsberg-Puckett A, Wurm Johansson G, Regner S. Presentation of gastrointestinal bleeding in patients with antithrombotic therapy, results from a consecutive retrospective cohort. Scand J Trauma Resusc Emerg Med. 2025 Sep 10;33(1):146. doi: 10.1186/s13049-025-01431-1.
- Individual participant dataSharing planned: Yes. IPD will be shared after publication of studies from this trial upon request from publishers or other researchers. Only coded data will be shared and all sharing will be done according to the GDPR regulations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sara Regnér, PhD principal investigator
Region Skane
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Risk Factors and Complication of Surgical Procedure, run by Region Skane at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sara Regnér, PhD (040 33 10 00, sara.regner@med.lu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: 5 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05195697, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2026.