Perioperative ComplicationRAMPNCT05869578
Registry of Anesthesia and Perioperative Medicine
An observational study of Perioperative Complication and Perioperative/Postoperative Complications, run by Clinica Alemana de Santiago at 1 site in Chile.
Trial summary
To assess mortality and morbidity associated to anesthesia interventions Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Perioperative Complication, Perioperative/Postoperative Complications, Anesthesia Morbidity
- What is being tested?
- Anesthesia Intervention
- Type of treatment
- Surgery or procedure
- How many people
- 10,000 participants
- Where
- 1 siteChile
- Study dates
- 1 Jun 2023to 1 Jan 2045
- How long will I take part?
- 1 Year
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Individuals of all ages being admitted at Clinica Alemana de Santiago that will require or were in care by an anesthesiologist.
Who may be able to join
- All individuals
- Individuals agreeing to participate in the study by signing a consent
Who cannot join
- The subjects who had insufficient data in their files
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Chile1 site
Clinica Alemana de Santiago
Santiago, Santiago Metropolitan, 7591538
Patricio A Leyton, MD, +562222101111 ext. 1699, pleytonb@alemana.cl
Javiera A Vargas, MD
About this study
Official title: Registry of Patients Subjected to the Perioperative Care of the Anesthesia Service of Clinica Alemana of Santiago Chile
To assess mortality and morbidity associated to anesthesia interventions
Read the detailed description
Currently evidence-based medicine is one of the most important tools guiding our medical practice. Part of this evidence has been generated from clinical records, which has allowed access to large databases from which relevant information has been obtained for perioperative risk stratification, searching for complications, having specific information on procedures, among others.
A clear example, especially useful daily in anesthesia work, is the NSQIP score, a tool that allows calculating perioperative risk according to the conditions of the patient and the surgery. NSQIP score is considered to make decisions in both the American and the European guidelines for preoperative evaluation for surgery.
Latin-American or Chilean databases are not available at the present time. Chile lacks of population perioperative databases, methodology and practice of medicine outcomes records, thus making necessary the generation of a retrospective/prospective registry.
The investigators expect that this registry will allow the collection of perioperative information appropriate to characterize the Chilean population, observe its evolution, and detect risk factors. Moreover, this registry will grant the investigators the means to design new research studies that may allow them to gather medical evidence of superior quality, thus benefiting patients with the best and safest interventions and procedures.
- Conditions
- Perioperative Complication, Perioperative/Postoperative Complications, Anesthesia Morbidity, Anesthesia; Adverse Effect, Anesthesia Complication, Anesthesia; Reaction
- Being tested
- Anesthesia Intervention
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anesthesia InterventionProcedure or surgery
Patients exposed to any anesthesia intervention will be assessed to whether the exposure to anesthesia confers a risk for perioperative outcomes
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality rate in the postoperative period
Posoperative mortality of individuals exposed to any anesthesia related intervention or event
Measured: 30 days
All-cause mortality rate in the posoperative period
Posoperative mortality of individuals exposed to any anesthesia related intervention or event
Measured: one year
Number of patients presenting a complication in the posoperative period
Perioperative morbidity of individuals exposed to any anesthesia related intervention or event.
Measured: 30 days
Number of patients who needed rehospitalization in the posoperative period
Posoperative rehospitalization rate of individuals exposed to any anesthesia related intervention or event, after primary discharge
Measured: 7 days after primary discharge
Number of deaths in the postoperative period after readmission
In-hospital mortality of patients that were readmitted after primary discharge
Measured: up to 30 days
Secondary outcomes (4)
Change from baseline in pain, as measured by the visual analog scale (VAS)
Scores are measured on a 10-point VAS. The VAS ranges from 0 to 10 with 0 indicating no pain, and higher scores indicating greater pain.
Measured: Baseline pre-intervention VAS, postoperative/intervention 1 hour VAS, postoperative/intervention 24 hour VAS
Number of patients that develops postoperative acute kidney injury, as measured by Kidney Disease Improving Global Outcomes (KIDGO)-2012 serum creatinine criteria
Criteria for developing acute kidney injury are:
Increase in serum creatinin by ≽0.3 mg/dl (≽26.5lmol/l) within 48hours; or Increase in serum creatinine ≽1.5 times baseline, which is known or presumed to have occurred within the prior 7 days; or Urine volume < 0.5ml/kg/h for 6hours.
Measured: 7 and 30 days
Number of patients that develops postoperative Major Acute Cardiac Events (MACE), as defined by the American Heart Association
Criteria for MACE are the development of any of the following conditions Non-fatal stroke Non-fatal myocardial infarction Cardiovascular death
Measured: 7 and 30 days
Number of patients that develop posoperative chronic pain as measured by visual analog scale
Scores are measured on a 10-point VAS. The VAS ranges from 0 to 10 with 0 indicating no pain, and higher scores indicating greater pain.
Measured: 3, 6, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2023
- Study start1 Jun 2023 (estimated)
- Primary completion1 Jan 2035 (estimated)
- Study completion1 Jan 2045 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Perioperative ComplicationStudies of the same condition, open and under way.
- 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
- Other
- Enrolment
- 10,000 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Clinica Alemana de Santiago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05869578
- Sponsor's protocol ID
- UIEC1166
- Acronym
- RAMP
- Status last verified
- May 2023
- First submitted
- 27 Apr 2023
- Last updated
- 22 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Abdel-Kader AK, Eisenkraft JB, Katz DJ. Overview and Limitations of Database Research in Anesthesiology: A Narrative Review. Anesth Analg. 2021 Apr 1;132(4):1012-1022. doi: 10.1213/ANE.0000000000005346.
PubMed 33346984Kristensen SD, Knuuti J, Saraste A, Anker S, Botker HE, De Hert S, Ford I, Gonzalez Juanatey JR, Gorenek B, Heyndrickx GR, Hoeft A, Huber K, Iung B, Kjeldsen KP, Longrois D, Luescher TF, Pierard L, Pocock S, Price S, Roffi M, Sirnes PA, Uva MS, Voudris V, Funck-Brentano C; Authors/Task Force Members. 2014 ESC/ESA Guidelines on non-cardiac surgery: cardiovascular assessment and management: The Joint Task Force on non-cardiac surgery: cardiovascular assessment and management of the European Society of Cardiology (ESC) and the European Society of Anaesthesiology (ESA). Eur J Anaesthesiol. 2014 Oct;31(10):517-73. doi: 10.1097/EJA.0000000000000150. No abstract available.
PubMed 25127426Gupta PK, Gupta H, Sundaram A, Kaushik M, Fang X, Miller WJ, Esterbrooks DJ, Hunter CB, Pipinos II, Johanning JM, Lynch TG, Forse RA, Mohiuddin SM, Mooss AN. Development and validation of a risk calculator for prediction of cardiac risk after surgery. Circulation. 2011 Jul 26;124(4):381-7. doi: 10.1161/CIRCULATIONAHA.110.015701. Epub 2011 Jul 5.
PubMed 21730309Fleisher LA, Fleischmann KE, Auerbach AD, Barnason SA, Beckman JA, Bozkurt B, Davila-Roman VG, Gerhard-Herman MD, Holly TA, Kane GC, Marine JE, Nelson MT, Spencer CC, Thompson A, Ting HH, Uretsky BF, Wijeysundera DN. 2014 ACC/AHA guideline on perioperative cardiovascular evaluation and management of patients undergoing noncardiac surgery: executive summary: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. Circulation. 2014 Dec 9;130(24):2215-45. doi: 10.1161/CIR.0000000000000105. Epub 2014 Aug 1. No abstract available.
PubMed 25085962Bosco E, Hsueh L, McConeghy KW, Gravenstein S, Saade E. Major adverse cardiovascular event definitions used in observational analysis of administrative databases: a systematic review. BMC Med Res Methodol. 2021 Nov 6;21(1):241. doi: 10.1186/s12874-021-01440-5.
PubMed 34742250
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Registry of Patients Subjected to the Perioperative Care of the Anesthesia Service of Clinica Alemana of Santiago Chile
- ClinicalTrials.gov ID
- NCT05869578
- Acronym / sponsor ID
- RAMP / UIEC1166
- Conditions
- Perioperative Complication, Perioperative/Postoperative Complications, Anesthesia Morbidity, Anesthesia; Adverse Effect, Anesthesia Complication, Anesthesia; Reaction
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Clinica Alemana de SantiagoUniversity, hospital or other
- Study start
- 1 Jun 2023 (estimated)
- Primary completion
- 1 Jan 2035 (estimated)
- Study completion
- 1 Jan 2045 (estimated)
- First posted
- 22 May 2023 (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.
To assess mortality and morbidity associated to anesthesia interventions
Detailed description
Currently evidence-based medicine is one of the most important tools guiding our medical practice. Part of this evidence has been generated from clinical records, which has allowed access to large databases from which relevant information has been obtained for perioperative risk stratification, searching for complications, having specific information on procedures, among others.
A clear example, especially useful daily in anesthesia work, is the NSQIP score, a tool that allows calculating perioperative risk according to the conditions of the patient and the surgery. NSQIP score is considered to make decisions in both the American and the European guidelines for preoperative evaluation for surgery.
Latin-American or Chilean databases are not available at the present time. Chile lacks of population perioperative databases, methodology and practice of medicine outcomes records, thus making necessary the generation of a retrospective/prospective registry.
The investigators expect that this registry will allow the collection of perioperative information appropriate to characterize the Chilean population, observe its evolution, and detect risk factors. Moreover, this registry will grant the investigators the means to design new research studies that may allow them to gather medical evidence of superior quality, thus benefiting patients with the best and safest interventions and procedures.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 1 Year
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Individuals of all ages being admitted at Clinica Alemana de Santiago that will require or were in care by an anesthesiologist.
Key inclusion criteria (2 listed)
- All individuals
- Individuals agreeing to participate in the study by signing a consent
Key exclusion criteria (1 listed)
- The subjects who had insufficient data in their files
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 |
|---|---|---|
| Anesthesia InterventionPatients exposed to any anesthesia intervention will be assessed to whether the exposure to anesthesia confers a risk for perioperative outcomes | Procedure or surgery | – |
Primary outcome
All-cause mortality rate in the postoperative period
Time frame: 30 days
Posoperative mortality of individuals exposed to any anesthesia related intervention or event
All-cause mortality rate in the posoperative period
Time frame: one year
Posoperative mortality of individuals exposed to any anesthesia related intervention or event
Number of patients presenting a complication in the posoperative period
Time frame: 30 days
Perioperative morbidity of individuals exposed to any anesthesia related intervention or event.
Number of patients who needed rehospitalization in the posoperative period
Time frame: 7 days after primary discharge
Posoperative rehospitalization rate of individuals exposed to any anesthesia related intervention or event, after primary discharge
Number of deaths in the postoperative period after readmission
Time frame: up to 30 days
In-hospital mortality of patients that were readmitted after primary discharge
4 secondary outcomes
Change from baseline in pain, as measured by the visual analog scale (VAS)
Time frame: Baseline pre-intervention VAS, postoperative/intervention 1 hour VAS, postoperative/intervention 24 hour VAS
Number of patients that develops postoperative acute kidney injury, as measured by Kidney Disease Improving Global Outcomes (KIDGO)-2012 serum creatinine criteria
Time frame: 7 and 30 days
Number of patients that develops postoperative Major Acute Cardiac Events (MACE), as defined by the American Heart Association
Time frame: 7 and 30 days
Number of patients that develop posoperative chronic pain as measured by visual analog scale
Time frame: 3, 6, and 12 months
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 22 May 2023.
- Background: PubMed 33346984Abdel-Kader AK, Eisenkraft JB, Katz DJ. Overview and Limitations of Database Research in Anesthesiology: A Narrative Review. Anesth Analg. 2021 Apr 1;132(4):1012-1022. doi: 10.1213/ANE.0000000000005346.
- Background: PubMed 25127426Kristensen SD, Knuuti J, Saraste A, Anker S, Botker HE, De Hert S, Ford I, Gonzalez Juanatey JR, Gorenek B, Heyndrickx GR, Hoeft A, Huber K, Iung B, Kjeldsen KP, Longrois D, Luescher TF, Pierard L, Pocock S, Price S, Roffi M, Sirnes PA, Uva MS, Voudris V, Funck-Brentano C; Authors/Task Force Members. 2014 ESC/ESA Guidelines on non-cardiac surgery: cardiovascular assessment and management: The Joint Task Force on non-cardiac surgery: cardiovascular assessment and management of the European Society of Cardiology (ESC) and the European Society of Anaesthesiology (ESA). Eur J Anaesthesiol. 2014 Oct;31(10):517-73. doi: 10.1097/EJA.0000000000000150. No abstract available.
- Background: PubMed 21730309Gupta PK, Gupta H, Sundaram A, Kaushik M, Fang X, Miller WJ, Esterbrooks DJ, Hunter CB, Pipinos II, Johanning JM, Lynch TG, Forse RA, Mohiuddin SM, Mooss AN. Development and validation of a risk calculator for prediction of cardiac risk after surgery. Circulation. 2011 Jul 26;124(4):381-7. doi: 10.1161/CIRCULATIONAHA.110.015701. Epub 2011 Jul 5.
- Background: PubMed 25085962Fleisher LA, Fleischmann KE, Auerbach AD, Barnason SA, Beckman JA, Bozkurt B, Davila-Roman VG, Gerhard-Herman MD, Holly TA, Kane GC, Marine JE, Nelson MT, Spencer CC, Thompson A, Ting HH, Uretsky BF, Wijeysundera DN. 2014 ACC/AHA guideline on perioperative cardiovascular evaluation and management of patients undergoing noncardiac surgery: executive summary: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. Circulation. 2014 Dec 9;130(24):2215-45. doi: 10.1161/CIR.0000000000000105. Epub 2014 Aug 1. No abstract available.
- Background: PubMed 34742250Bosco E, Hsueh L, McConeghy KW, Gravenstein S, Saade E. Major adverse cardiovascular event definitions used in observational analysis of administrative databases: a systematic review. BMC Med Res Methodol. 2021 Nov 6;21(1):241. doi: 10.1186/s12874-021-01440-5.
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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.
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 Perioperative Complication and Perioperative/Postoperative Complications, run by Clinica Alemana de Santiago at 1 site in Chile.
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 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: opening soon, as of the sponsor's last update on 22 May 2023. 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 Chile. 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 Javiera A Vargas, MD (+56222101111 ext. 1699, jvargasz@alemana.cl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause mortality rate in the postoperative period (time frame: 30 days). The study lists 5 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 NCT05869578, which also lists 5 linked publications.
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 22 May 2023.