Perioperative/Postoperative Complications Clinical Trial
— RAMPOfficial 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
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 |
Country | Name | City | State |
---|---|---|---|
Chile | Clinica Alemana de Santiago | Santiago | Region Metropolitana De Santiago |
Lead Sponsor | Collaborator |
---|---|
Clinica Alemana de Santiago |
Chile,
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
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 |
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