Systemic Inflammatory Response SyndromeNCT02563652
Can Biomarkers Aid in the Prediction of Postoperative Pain and Circulatory Instability After Major Abdominal Surgery?
An observational study of Systemic Inflammatory Response Syndrome, run by St. Olavs Hospital at 2 sites in 2 countries.
Trial summary
Patients undergoing major surgery are exposed to extensive damage of tissues, which induces widespread activation of the inflammatory system, called 'systemic inflammatory response syndrome' (SIRS).This activation of the inflammatory system may induce instability of the heart and respiration in the postoperative… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Systemic Inflammatory Response Syndrome
- How many people
- 101 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Sep 2015to Sep 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult, Older adult
Study population: Patients eligible for major abdominal surgery in St Olavs Hospital, Trondheim, Norway
Who may be able to join
- Patients undergoing major abdominal surgery (e.g. Whipple's operation, liver resection, abdominoperineal resection, vascular abdominal surgery etc.)
- Scheduled for PACU stay first 24 hours
Who cannot join
- Pregnancy
- Jehovah's witness
- Dementia
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: Can Biomarkers Aid in the Prediction of Postoperative Pain and Circulatory Instability After Major Abdominal Surgery? A Prospective Observational Study
Patients undergoing major surgery are exposed to extensive damage of tissues, which induces widespread activation of the inflammatory system, called 'systemic inflammatory response syndrome' (SIRS).This activation of the inflammatory system may induce instability of the heart and respiration in the postoperative period. The degree of physiologic response to postoperative SIRS as well as the degree of postoperative pain differ between patients. Therefore, patients undergoing anesthesia and major surgery are treated in a 'post anesthesia care unit' (PACU) after end of surgery.Admittance to a PACU is expensive. The time patients need to stay in a PACU after major surgery has not been extensively studied, and more appropriate tools for prediction of length of stay are needed.
The main aim of this study is to assess whether clinical observations, inflammatory biomarkers or genetic markers may aid in the prediction of physiological instability and/or pain after major surgery. Such predictors would help clinicians planning the length of PACU-stays.
- Conditions
- Systemic Inflammatory Response Syndrome
- Keywords
- Abdomen/surgery, Biological markers, Length of stay, Postoperative care, Anesthesia recovery period, Prognosis
- Medical subject headings
- Systemic Inflammatory Response Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Major abdominal surgery | Patients undergoing major abdominal surgery (laparotomy). Surgical procedures considered for inclusion include, but are not restricted to, procedures such as gastrectomy, pancreatic surgery, liver resection, open prostatectomy, colonic surgery, radical cystectomy with ileal conduit, open nephrectomy and vascular abdominal aortic surgery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to established circulatory stability for > 2 hours [Time to event outcome]
Circulatory stability will be assessed by applying a multi-state statistical model, where any state changes are measured at an hourly basis. The model will include variables reflecting the circulatory state of the patient, including heart rate, systolic blood pressure (or MAP) and lactate, which will be assessed together with the measures needed to maintain them, such as the amount of fluid given (ml per hour) and the extent of vasopressor (i.e. norepinephrine). The main outcome variable will be the time needed to reach the state of 'stable without intervention for more than two hours. To be classified in this state, the systolic blood pressure must be > 100 mmHg, the heart rate between 40 and 110, the patient must be off vasopressor and has a fluid requirement of less than 250 ml/hour.
Measured: 48 hours
Time to reaching a state of no or mild pain problem for > 2 hours [Time to event outcome]
This outcome will be reached when the patient has a numeric rating score (NRS) with respect to pain of < 4 and the opioid consumption is less than 5 mg morphine equivalents per hour.
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2015 (estimated)
- Study startSep 2015
- Primary completionSep 2018
- Study completionSep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Inflammatory Response SyndromeStudies of the same condition, open and under way.
- More trials run by St. Olavs HospitalThe 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
- Prospective
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Olavs Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Parma, Study in Multidisciplinary Pain Research Group, Italy, Fondazione IRCCS Policlinico San Matteo di Pavia
- Responsible party
- Sponsor
- Investigators
- Erik Solligård, phd md, Study director, St. Olavs Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02563652
- Sponsor's protocol ID
- 2015/641
- Status last verified
- Nov 2018
- First submitted
- 8 Sep 2015
- Last updated
- 14 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Biomarkers Aid in the Prediction of Postoperative Pain and Circulatory Instability After Major Abdominal Surgery? A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT02563652
- Acronym / sponsor ID
- 2015/641
- Conditions
- Systemic Inflammatory Response Syndrome
- Keywords
- Abdomen/surgery, Biological markers, Length of stay, Postoperative care, Anesthesia recovery period, Prognosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- St. Olavs HospitalUniversity, hospital or other
- Collaborators
- University of Parma, Study in Multidisciplinary Pain Research Group, Italy, Fondazione IRCCS Policlinico San Matteo di Pavia
- Study start
- Sep 2015 (actual)
- Primary completion
- Sep 2018 (actual)
- Study completion
- Sep 2018 (actual)
- First posted
- 30 Sep 2015 (estimated)
- 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.
Patients undergoing major surgery are exposed to extensive damage of tissues, which induces widespread activation of the inflammatory system, called 'systemic inflammatory response syndrome' (SIRS).This activation of the inflammatory system may induce instability of the heart and respiration in the postoperative period. The degree of physiologic response to postoperative SIRS as well as the degree of postoperative pain differ between patients. Therefore, patients undergoing anesthesia and major surgery are treated in a 'post anesthesia care unit' (PACU) after end of surgery.Admittance to a PACU is expensive. The time patients need to stay in a PACU after major surgery has not been extensively studied, and more appropriate tools for prediction of length of stay are needed.
The main aim of this study is to assess whether clinical observations, inflammatory biomarkers or genetic markers may aid in the prediction of physiological instability and/or pain after major surgery. Such predictors would help clinicians planning the length of PACU-stays.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Major abdominal surgery | – | –Patients undergoing major abdominal surgery (laparotomy). Surgical procedures considered for inclusion include, but are not restricted to, procedures such as gastrectomy, pancreatic surgery, liver resection, open prostatectomy, colonic surgery, radical cystectomy with ileal conduit, open nephrectomy and vascular abdominal aortic surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients eligible for major abdominal surgery in St Olavs Hospital, Trondheim, Norway
Key inclusion criteria (2 listed)
- Patients undergoing major abdominal surgery (e.g. Whipple's operation, liver resection, abdominoperineal resection, vascular abdominal surgery etc.)
- Scheduled for PACU stay first 24 hours
Key exclusion criteria (3 listed)
- Pregnancy
- Jehovah's witness
- Dementia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Time to established circulatory stability for > 2 hours [Time to event outcome]
Time frame: 48 hours
Circulatory stability will be assessed by applying a multi-state statistical model, where any state changes are measured at an hourly basis. The model will include variables reflecting the circulatory state of the patient, including heart rate, systolic blood pressure (or MAP) and lactate, which will be assessed together with the measures needed to maintain them, such as the amount of fluid given (ml per hour) and the extent of vasopressor (i.e. norepinephrine). The main outcome variable will be the time needed to reach the state of 'stable without intervention for more than two hours. To be classified in this state, the systolic blood pressure must be > 100 mmHg, the heart rate between 40 and 110, the patient must be off vasopressor and has a fluid requirement of less than 250 ml/hour.
Time to reaching a state of no or mild pain problem for > 2 hours [Time to event outcome]
Time frame: 48 hours
This outcome will be reached when the patient has a numeric rating score (NRS) with respect to pain of < 4 and the opioid consumption is less than 5 mg morphine equivalents per hour.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2018.
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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. This study is not recruiting at the moment.
Erik Solligård, phd md study director
St. Olavs Hospital
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Systemic Inflammatory Response Syndrome, run by St. Olavs Hospital at 2 sites in 2 countries.
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 2 inclusion and 3 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: finished, as of the sponsor's last update on 14 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy, Norway. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to established circulatory stability for > 2 hours [Time to event outcome] (time frame: 48 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Nov 2018.