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NCT Number: NCT05869578

Registry of Anesthesia and Perioperative Medicine

To assess mortality and morbidity associated to anesthesia interventions

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Clinica Alemana de Santiago

Santiago, Santiago Metropolitan, 7591538, Chile

Location contact

Javiera A Vargas, MD

PRINCIPAL_INVESTIGATOR

Patricio A Leyton, MD

CONTACT

[email protected]

+562222101111 ext. 1699

Patricio A Leyton, MD

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Anesthesia Intervention

Procedure

Patients exposed to any anesthesia intervention will be assessed to whether the exposure to anesthesia confers a risk for perioperative outcomes

Primary outcomes

  1. All-cause mortality rate in the postoperative period

    Time frame: 30 days

    Posoperative mortality of individuals exposed to any anesthesia related intervention or event

  2. All-cause mortality rate in the posoperative period

    Time frame: one year

    Posoperative mortality of individuals exposed to any anesthesia related intervention or event

  3. 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.

  4. 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

  5. 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

Secondary outcomes

  1. 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

    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.

  2. 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

    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.

  3. Number of patients that develops postoperative Major Acute Cardiac Events (MACE), as defined by the American Heart Association

    Time frame: 7 and 30 days

    Criteria for MACE are the development of any of the following conditions Non-fatal stroke Non-fatal myocardial infarction Cardiovascular death

  4. Number of patients that develop posoperative chronic pain as measured by visual analog scale

    Time frame: 3, 6, and 12 months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Javiera A Vargas, MD

CONTACT

[email protected]

+56222101111 ext. 1699

Patricio A Leyton, MD

CONTACT

[email protected]

+5622101111 ext. 1699

Sponsors and collaborators

Lead sponsor

Clinica Alemana de Santiago

Other

Registry information

Official study title

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

Acronym: RAMP

Important dates

Study start
2023
Primary completion
2035
Study completion
2045
First posted
May 22, 2023
Registry last updated
May 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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