Registry of Anesthesia and Perioperative Medicine

Perioperative/Postoperative Complications Clinical Trial

— RAMP  

Official title:

Registry of Patients Subjected to the Perioperative Care of the Anesthesia Service of Clinica Alemana of Santiago Chile

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05869578
• Other study ID #: UIEC1166
• Status: Not yet recruiting
• Start date: June 1, 2023
• Est. completion date: January 1, 2045

Study information

• Verified date: May 2023
• Source: Clinica Alemana de Santiago
• Contact: Javiera A Vargas, MD
• Phone: +56222101111
• Email: jvargasz[@]alemana.cl
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

To assess mortality and morbidity associated to anesthesia interventions

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10000
• Est. completion date: January 1, 2045
• Est. primary completion date: January 1, 2035
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• All individuals

• Individuals agreeing to participate in the study by signing a consent

Exclusion Criteria:

• The subjects who had insufficient data in their files

Related Conditions & MeSH terms

• Anesthesia Complication
• Anesthesia Morbidity
• Anesthesia; Adverse Effect
• Anesthesia; Reaction
• Perioperative Complication
• Perioperative/Postoperative Complications
• Postoperative Complications

Intervention

Procedure:
• Anesthesia Intervention
Patients exposed to any anesthesia intervention will be assessed to whether the exposure to anesthesia confers a risk for perioperative outcomes

Locations

Country	Name	City	State
Chile	Clinica Alemana de Santiago	Santiago	Region Metropolitana De Santiago

Sponsors (1)

Lead Sponsor	Collaborator
Clinica Alemana de Santiago

Country where clinical trial is conducted

Chile, 

References & Publications (5)

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. — View Citation

Bosco 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. — View Citation

Fleisher 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. — View Citation

Gupta 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. — View Citation

Kristensen 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All-cause mortality rate in the postoperative period	Posoperative mortality of individuals exposed to any anesthesia related intervention or event	30 days
Primary	All-cause mortality rate in the posoperative period	Posoperative mortality of individuals exposed to any anesthesia related intervention or event	one year
Primary	Number of patients presenting a complication in the posoperative period	Perioperative morbidity of individuals exposed to any anesthesia related intervention or event.	30 days
Primary	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	7 days after primary discharge
Primary	Number of deaths in the postoperative period after readmission	In-hospital mortality of patients that were readmitted after primary discharge	up to 30 days
Secondary	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.	Baseline pre-intervention VAS, postoperative/intervention 1 hour VAS, postoperative/intervention 24 hour VAS
Secondary	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.	7 and 30 days
Secondary	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	7 and 30 days
Secondary	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.	3, 6, and 12 months