Emergency SurgeryNCT06549101
NLR and Emergency Surgery
An observational study of Emergency Surgery, run by University of Chile at 1 site in Chile.
Trial summary
In the immune system, it has been observed that the preoperative neutrophil-to-lymphocyte ratio (NLR) is an index that reflects the state of inflammation and oxidative stress. In the perioperative period, NLR has been described as a predictor for patients who will develop renal injury, ischemic stroke, and myocardial… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Emergency Surgery
- How many people
- 851 participants
- Where
- 1 siteChile
- Study dates
- 23 Sep 2022to 30 Dec 2023
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Emergency patients operated on at the Clinical Hospital of the University of Chile between January and December 2021
Who may be able to join
- Availability of complete blood count in electronic medical records of all patients operated on between January and December 2021
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
Chile1 site
Hospital Clínico de la Universidad de Chile
Santiago, Santiago Metropolitan, 8380456
About this study
Official title: Neutrophil-to-Lymphocyte Ratio and Mortality After Emergency Surgery
In the immune system, it has been observed that the preoperative neutrophil-to-lymphocyte ratio (NLR) is an index that reflects the state of inflammation and oxidative stress. In the perioperative period, NLR has been described as a predictor for patients who will develop renal injury, ischemic stroke, and myocardial injury. Since preoperative inflammation is a predictor of morbidity and mortality in patients undergoing non-cardiac surgery, a retrospective analysis of the inflammatory status of patients undergoing surgery at the center is proposed.
Read the detailed description
A retrospective analysis of patients operated on at the Clinical Hospital of the University of Chile is proposed. The search will be conducted in the electronic medical records of all patients operated on between January and December 2021, with no exclusion criteria for this analysis. Demographic data, complications, length of hospital stay, and specific characteristics such as the need for mechanical ventilation, time spent in intermediate care units, and ICU as well as total hospitalization time will be recorded. For the purpose of this study, the preoperative complete blood count of the patients will be analyzed to search for hematological variables that reflect the state of preoperative systemic inflammation.
- Conditions
- Emergency Surgery
- Keywords
- Neutrophil-to-lymphocyte ratio, Emergency surgery, NLR
What is being measured
The primary outcome is the main question the study is designed to answer.
NLR
Preoperative neutrophil-to-lymphocyte ratio
Measured: Day of surgery
Mortality
30 and 180 days mortality
Measured: 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2024
- Study start23 Sep 2022
- Primary completion30 Dec 2023
- Study completion30 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Emergency SurgeryStudies 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 851 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chile
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Felipe Maldonado, M.D., M. Sc., Study chair, Hospital Clínico de la Universidad de Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06549101
- Sponsor's protocol ID
- OAIC 37/22
- Status last verified
- Aug 2024
- First submitted
- 7 Aug 2024
- Last updated
- 16 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Maldonado F, Albornoz M, Enriquez I, Espinoza C, Chang H, Carrasco L, Diaz-Papapietro C, Medina F, Gonzalez R, Caceres M. Association of neutrophil-to-lymphocyte ratio with age and 180-day mortality after emergency surgery. BMC Anesthesiol. 2024 Sep 17;24(1):329. doi: 10.1186/s12871-024-02718-z.
PubMed 39289610
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neutrophil-to-Lymphocyte Ratio and Mortality After Emergency Surgery
- ClinicalTrials.gov ID
- NCT06549101
- Acronym / sponsor ID
- OAIC 37/22
- Conditions
- Emergency Surgery
- Keywords
- Neutrophil-to-lymphocyte ratio, Emergency surgery, NLR
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 851 participants (actual)
- Lead sponsor
- University of ChileUniversity, hospital or other
- Study start
- 23 Sep 2022 (actual)
- Primary completion
- 30 Dec 2023 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 12 Aug 2024 (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.
In the immune system, it has been observed that the preoperative neutrophil-to-lymphocyte ratio (NLR) is an index that reflects the state of inflammation and oxidative stress. In the perioperative period, NLR has been described as a predictor for patients who will develop renal injury, ischemic stroke, and myocardial injury. Since preoperative inflammation is a predictor of morbidity and mortality in patients undergoing non-cardiac surgery, a retrospective analysis of the inflammatory status of patients undergoing surgery at the center is proposed.
Detailed description
A retrospective analysis of patients operated on at the Clinical Hospital of the University of Chile is proposed. The search will be conducted in the electronic medical records of all patients operated on between January and December 2021, with no exclusion criteria for this analysis. Demographic data, complications, length of hospital stay, and specific characteristics such as the need for mechanical ventilation, time spent in intermediate care units, and ICU as well as total hospitalization time will be recorded. For the purpose of this study, the preoperative complete blood count of the patients will be analyzed to search for hematological variables that reflect the state of preoperative systemic inflammation.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Emergency patients operated on at the Clinical Hospital of the University of Chile between January and December 2021
Key inclusion criteria (1 listed)
- Availability of complete blood count in electronic medical records of all patients operated on between January and December 2021
Key exclusion criteria (1 listed)
- None
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
NLR
Time frame: Day of surgery
Preoperative neutrophil-to-lymphocyte ratio
Mortality
Time frame: 6 months after surgery
30 and 180 days mortality
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 16 Dec 2024.
- Derived from this study: PubMed 39289610Maldonado F, Albornoz M, Enriquez I, Espinoza C, Chang H, Carrasco L, Diaz-Papapietro C, Medina F, Gonzalez R, Caceres M. Association of neutrophil-to-lymphocyte ratio with age and 180-day mortality after emergency surgery. BMC Anesthesiol. 2024 Sep 17;24(1):329. doi: 10.1186/s12871-024-02718-z.
- Individual participant dataSharing planned: No
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Chronic Pain
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.
Felipe Maldonado, M.D., M. Sc. study chair
Hospital Clínico de la Universidad de Chile
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 Emergency Surgery, run by University of Chile 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 1 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: finished, as of the sponsor's last update on 16 Dec 2024. 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?
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?
NLR (time frame: Day of surgery). 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?
On the ClinicalTrials.gov record for NCT06549101, which also lists 1 linked publication.
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 16 Dec 2024.