Critical IllnessTraViIINCT06731296
General Surgery Patients at the Intensive Care Unit
An observational study of Critical Illness and Postoperative Complications, run by Hospital Departamental de Villavicencio at 2 sites in Colombia.
Trial summary
Introduction: high-risk surgical patients in the intensive care unit (ICU) are a unique population that has yet to be carefully monitored. Unlike most publications, which focus on general ICU patients, this study aims to fill a gap by specifically evaluating factors associated with lethal outcomes for surgical… Read more about this study
- Who is it for?
- Ages 15 to 100 years
- Conditions the study is for
- Critical Illness, Postoperative Complications
- What is being tested?
- Presence of a risk factor
- How many people
- 1,000 participants
- Where
- 2 sitesColombia
- Study dates
- Aug 2026to Jan 2029
- 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 15 to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: General surgery patients admitted to the ICU, especially for postoperative care.
Who may be able to join
- Patients with a surgical diagnosis admitted to the ICU.
- Patients in the operative period admitted to the ICU.
Who cannot join
- Patients admitted from another hospital.
- Surgical procedures performed in another hospital.
- Surgical patients referred to another hospital.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Colombia2 sites
Clinica Primavera
Villavicencio, Meta Department, 50001
Norton Perez, MD, 3112517471, norton.perez@hotmail.com
Norton Perez, MD
Hospital Departamental de Villavicencio
Villavicencio, Meta Department, 50001
Norton Perez, MD, 3112517471, norton.perez@hotmail.com
Norton Perez, MD
About this study
Official title: Characteristics of General Surgery Patients Admitted to the Intensive Care Unit, Villavicencio, 2022-2024.
Introduction: high-risk surgical patients in the intensive care unit (ICU) are a unique population that has yet to be carefully monitored. Unlike most publications, which focus on general ICU patients, this study aims to fill a gap by specifically evaluating factors associated with lethal outcomes for surgical patients in the ICU.
Methodology: An analytical cross-sectional trial was designed to answer the research question and be performed it in one or two institutions with a median and high complexity of care in the Orinoco region. ICU discharge book registries will be selected from a post-pandemic period (2022-2024). Adult and pediatric patients admitted from the surgical theatre by emergency or elective surgical procedures or with ICD-10 (International Classification of Diseases 10th revision) codes related to the pediatric or general surgery specialty. The frequency and proportion of categorical variables and the central distribution and dispersion of quantitative variables will be described. Chi-square and U-Mann \& Whitney tests will be used to compare variables. A p-value <0.05 will be selected as statistical significance.
Read more
Results: The researchers expect to find the demographic characteristics of surgical patients admitted to the ICU by diagnostic groups and by severity associated with mortality.
Conclusions: The trial, which is both feasible and necessary, has the potential to provide valuable insights into the factors affecting outcomes for high-risk surgical patients at the ICU. This knowledge could lead to improved patient care and outcomes, making the research essential and highly beneficial.
Read the detailed description
Introduction: high-risk surgical patients in the intensive care unit (ICU) are a unique population that has yet to be carefully monitored to minimize surgical or non-surgical complications. It is necessary to identify factors associated with adverse outcomes. Unlike most publications, which focus on general ICU patients, this study aims to fill a gap by specifically evaluating factors associated with lethal outcomes for surgical patients in the ICU.
Methodology: An analytical cross-sectional trial was designed to answer the research question and be performed it in one or two institutions with a median and high complexity of care in the Orinoco region. ICU discharge book registries will be selected from a post-pandemic period (2022-2024). Adult and pediatric patients admitted from the surgical theatre by emergency or elective surgical procedures or with ICD-10 (International Classification of Diseases 10th revision) codes related to the pediatric or general surgery specialty. The frequency and proportion of categorical variables and the central distribution and dispersion of quantitative variables will be described. Chi-square and U-Mann \& Whitney tests will be used to compare variables. A p-value <0.05 will be selected as statistical significance.
Results: The researchers expect to find the demographic characteristics of surgical patients admitted to the ICU by diagnostic groups and by severity associated with mortality to establish predictive models of adverse outcomes in the admission to the intensive care unit to implement early preventive interventions.
Conclusions: The trial, which is both feasible and necessary, has the potential to provide valuable insights into the factors affecting outcomes for high-risk surgical patients at the ICU. This knowledge could lead to improved patient care and outcomes, making the research essential and highly beneficial.
- Conditions
- Critical Illness, Postoperative Complications
- Being tested
- Presence of a risk factor
- Keywords
- Acute Care Surgery, Operative Surgical Procedures, Perioperative Care, Critical Care, Intensive Care Units, In-hospital Mortality, Colombia
- Medical subject headings
- Critical Illness, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Presence of a risk factorOther
Demographic, severity, type of surgery, diagnosis, diagnostic system, type of admission.
| Study group | Role | What they receive |
|---|---|---|
| Abdominal surgery | Patients admitted to the ICU after an abdominal surgery. Receives: Other: Presence of a risk factor | |
| Older adults | Older adults (65+) surgical patients admitted to the ICU. Receives: Other: Presence of a risk factor |
What is being measured
The primary outcome is the main question the study is designed to answer.
ICU mortality
ICU discharges due to patient death in the ICU.
Measured: 30 days
Secondary outcomes (1)
ICU length of stay
ICU length of stay
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2024
- Study startAug 2026 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionJan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Critical IllnessStudies 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
- Ecologic or community
- Time perspective
- Retrospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Departamental de Villavicencio
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Norton Perez-Gutierrez, MD, Hospital Departamental de Villavicencio
- Investigators
- Norton Perez, MD, Principal investigator, Universidad Cooperativa de Colombia; Hospital Departamental de Villavicencio; Clínica Primavera
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06731296
- Sponsor's protocol ID
- GRIVI_2024_01_QX_UCI
- Acronym
- TraViII
- Status last verified
- Nov 2025
- First submitted
- 9 Dec 2024
- Last updated
- 21 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data contains sensitive information of patients.
Publications
Dovzhanskiy DI, Schwab S, Bischoff MS, Brenner T, Weigand MA, Hinz U, Bockler D. Extended intensive care correlates with worsening of surgical outcome after elective abdominal aortic reconstruction. J Cardiovasc Surg (Torino). 2021 Dec;62(6):591-599. doi: 10.23736/S0021-9509.21.11842-7. Epub 2021 May 20.
PubMed 34014060Menzenbach J, Layer YC, Layer YL, Mayr A, Coburn M, Wittmann M, Hilbert T. The level of postoperative care influences mortality prediction by the POSPOM score: A retrospective cohort analysis. PLoS One. 2021 Sep 29;16(9):e0257829. doi: 10.1371/journal.pone.0257829. eCollection 2021.
PubMed 34587207Hynes AM, Lambe LD, Scantling DR, Bormann BC, Atkins JH, Rassekh CH, Seamon MJ, Martin ND. A surgical needs assessment for airway rapid responses: A retrospective observational study. J Trauma Acute Care Surg. 2022 Jan 1;92(1):126-134. doi: 10.1097/TA.0000000000003348.
PubMed 34252060Peters F, Hohenstein S, Bollmann A, Kuhlen R, Ritz JP. The Postoperative Utilization of Intensive Care Beds After Visceral Surgery Procedures. Dtsch Arztebl Int. 2023 Sep 22;120(38):633-638. doi: 10.3238/arztebl.m2023.0158.
PubMed 37427992Timan TJ, Karlsson O, Sernert N, Prytz M. Standardized perioperative management in acute abdominal surgery: Swedish SMASH controlled study. Br J Surg. 2023 May 16;110(6):710-716. doi: 10.1093/bjs/znad081.
PubMed 37071812Chinawong C, Utriyaprasit K, Sindhu S, Viwatwongkasem C, Suksompong S. Factors Influencing Pre-Cardiopulmonary Arrest Signs among Post-General Surgery Patients in Critical Care Service System. Int J Environ Res Public Health. 2023 Jan 3;20(1):876. doi: 10.3390/ijerph20010876.
PubMed 36613197Meschino MT, Vogt KN, Allen L, Saddik M, Nenshi R, Van Heest R, Saleh F, Widder S, Minor S, Joos E, Parry NG, Murphy PB, Ball CG, Hameed M, Engels PT; CANUCS (Canadian Collaborative on Urgent Care Surgery). Operating room use for emergency general surgery cases: analysis of the Patterns of Complex Emergency General Surgery in Canada study. Can J Surg. 2023 Jan 3;66(1):E13-E20. doi: 10.1503/cjs.008120. Print 2023 Jan-Feb.
PubMed 36596587Suarez-de-la-Rica A, Ripolles-Melchor J, Aldecoa C, Abad-Motos A, Ferrando C, Abad-Gurumeta A, Diaz-Almiron M, Gil-Lapetra C, Garcia-Miguel FJ, Pedregosa-Sanz A, Esteve-Perez N, Rodriguez-Jimenez R, Gimeno Fernandez P, Maseda E; POWER Study Investigators Group for the Spanish Perioperative Audit and Research Network (RedGERM-SPARN). Postoperative Critical Care Admission Was Not Associated with Improved Postoperative Outcomes in Elective Colorectal Surgery: Secondary Analysis Of POWER Trial. J Gastrointest Surg. 2023 Oct;27(10):2187-2198. doi: 10.1007/s11605-023-05780-z. Epub 2023 Aug 7.
PubMed 37550589Yohann A, Kayange L, Purcell L, Gallaher J, Charles A. Acute care surgery in a Malawian district hospital: Epidemiology, outcomes, and assessment of operative capacity. Trop Doct. 2023 Jan;53(1):73-80. doi: 10.1177/00494755221102226. Epub 2022 Jul 27.
PubMed 35895502Stahlschmidt A, Passos SC, Cardoso GR, Schuh GJ, Neto PCDS, Castro SMJ, Stefani LC. Postoperative intensive care allocation and mortality in high-risk surgical patients: evidence from a low- and middle-income country cohort. Braz J Anesthesiol. 2024 Jul-Aug;74(4):844517. doi: 10.1016/j.bjane.2024.844517. Epub 2024 May 23.
PubMed 38789003
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characteristics of General Surgery Patients Admitted to the Intensive Care Unit, Villavicencio, 2022-2024.
- ClinicalTrials.gov ID
- NCT06731296
- Acronym / sponsor ID
- TraViII / GRIVI_2024_01_QX_UCI
- Conditions
- Critical Illness, Postoperative Complications
- Keywords
- Acute Care Surgery, Operative Surgical Procedures, Perioperative Care, Critical Care, Intensive Care Units, In-hospital Mortality, Colombia
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Hospital Departamental de VillavicencioUniversity, hospital or other
- Study start
- Aug 2026 (estimated)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Jan 2029 (estimated)
- First posted
- 12 Dec 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.
Introduction: high-risk surgical patients in the intensive care unit (ICU) are a unique population that has yet to be carefully monitored. Unlike most publications, which focus on general ICU patients, this study aims to fill a gap by specifically evaluating factors associated with lethal outcomes for surgical patients in the ICU.
Methodology: An analytical cross-sectional trial was designed to answer the research question and be performed it in one or two institutions with a median and high complexity of care in the Orinoco region. ICU discharge book registries will be selected from a post-pandemic period (2022-2024). Adult and pediatric patients admitted from the surgical theatre by emergency or elective surgical procedures or with ICD-10 (International Classification of Diseases 10th revision) codes related to the pediatric or general surgery specialty. The frequency and proportion of categorical variables and the central distribution and dispersion of quantitative variables will be described. Chi-square and U-Mann \& Whitney tests will be used to compare variables. A p-value <0.05 will be selected as statistical significance.
Results: The researchers expect to find the demographic characteristics of surgical patients admitted to the ICU by diagnostic groups and by severity associated with mortality.
Conclusions: The trial, which is both feasible and necessary, has the potential to provide valuable insights into the factors affecting outcomes for high-risk surgical patients at the ICU. This knowledge could lead to improved patient care and outcomes, making the research essential and highly beneficial.
Detailed description
Introduction: high-risk surgical patients in the intensive care unit (ICU) are a unique population that has yet to be carefully monitored to minimize surgical or non-surgical complications. It is necessary to identify factors associated with adverse outcomes. Unlike most publications, which focus on general ICU patients, this study aims to fill a gap by specifically evaluating factors associated with lethal outcomes for surgical patients in the ICU.
Methodology: An analytical cross-sectional trial was designed to answer the research question and be performed it in one or two institutions with a median and high complexity of care in the Orinoco region. ICU discharge book registries will be selected from a post-pandemic period (2022-2024). Adult and pediatric patients admitted from the surgical theatre by emergency or elective surgical procedures or with ICD-10 (International Classification of Diseases 10th revision) codes related to the pediatric or general surgery specialty. The frequency and proportion of categorical variables and the central distribution and dispersion of quantitative variables will be described. Chi-square and U-Mann \& Whitney tests will be used to compare variables. A p-value <0.05 will be selected as statistical significance.
Results: The researchers expect to find the demographic characteristics of surgical patients admitted to the ICU by diagnostic groups and by severity associated with mortality to establish predictive models of adverse outcomes in the admission to the intensive care unit to implement early preventive interventions.
Conclusions: The trial, which is both feasible and necessary, has the potential to provide valuable insights into the factors affecting outcomes for high-risk surgical patients at the ICU. This knowledge could lead to improved patient care and outcomes, making the research essential and highly beneficial.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Abdominal surgery | – | Other: Presence of a risk factorPatients admitted to the ICU after an abdominal surgery. |
| Older adults | – | Other: Presence of a risk factorOlder adults (65+) surgical patients admitted to the ICU. |
Who may qualify
- Ages
- 15 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- General surgery patients admitted to the ICU, especially for postoperative care.
Key inclusion criteria (2 listed)
- Patients with a surgical diagnosis admitted to the ICU.
- Patients in the operative period admitted to the ICU.
Key exclusion criteria (3 listed)
- Patients admitted from another hospital.
- Surgical procedures performed in another hospital.
- Surgical patients referred to another hospital.
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 |
|---|---|---|
| Presence of a risk factorDemographic, severity, type of surgery, diagnosis, diagnostic system, type of admission. | Other | Abdominal surgery, Older adults |
Primary outcome
ICU mortality
Time frame: 30 days
ICU discharges due to patient death in the ICU.
1 secondary outcome
ICU length of stay
Time frame: 30 days
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 21 Nov 2025.
- Results publication: PubMed 34014060Dovzhanskiy DI, Schwab S, Bischoff MS, Brenner T, Weigand MA, Hinz U, Bockler D. Extended intensive care correlates with worsening of surgical outcome after elective abdominal aortic reconstruction. J Cardiovasc Surg (Torino). 2021 Dec;62(6):591-599. doi: 10.23736/S0021-9509.21.11842-7. Epub 2021 May 20.
- Results publication: PubMed 34587207Menzenbach J, Layer YC, Layer YL, Mayr A, Coburn M, Wittmann M, Hilbert T. The level of postoperative care influences mortality prediction by the POSPOM score: A retrospective cohort analysis. PLoS One. 2021 Sep 29;16(9):e0257829. doi: 10.1371/journal.pone.0257829. eCollection 2021.
- Results publication: PubMed 34252060Hynes AM, Lambe LD, Scantling DR, Bormann BC, Atkins JH, Rassekh CH, Seamon MJ, Martin ND. A surgical needs assessment for airway rapid responses: A retrospective observational study. J Trauma Acute Care Surg. 2022 Jan 1;92(1):126-134. doi: 10.1097/TA.0000000000003348.
- Results publication: PubMed 37427992Peters F, Hohenstein S, Bollmann A, Kuhlen R, Ritz JP. The Postoperative Utilization of Intensive Care Beds After Visceral Surgery Procedures. Dtsch Arztebl Int. 2023 Sep 22;120(38):633-638. doi: 10.3238/arztebl.m2023.0158.
- Results publication: PubMed 37071812Timan TJ, Karlsson O, Sernert N, Prytz M. Standardized perioperative management in acute abdominal surgery: Swedish SMASH controlled study. Br J Surg. 2023 May 16;110(6):710-716. doi: 10.1093/bjs/znad081.
- Results publication: PubMed 36613197Chinawong C, Utriyaprasit K, Sindhu S, Viwatwongkasem C, Suksompong S. Factors Influencing Pre-Cardiopulmonary Arrest Signs among Post-General Surgery Patients in Critical Care Service System. Int J Environ Res Public Health. 2023 Jan 3;20(1):876. doi: 10.3390/ijerph20010876.
- Results publication: PubMed 36596587Meschino MT, Vogt KN, Allen L, Saddik M, Nenshi R, Van Heest R, Saleh F, Widder S, Minor S, Joos E, Parry NG, Murphy PB, Ball CG, Hameed M, Engels PT; CANUCS (Canadian Collaborative on Urgent Care Surgery). Operating room use for emergency general surgery cases: analysis of the Patterns of Complex Emergency General Surgery in Canada study. Can J Surg. 2023 Jan 3;66(1):E13-E20. doi: 10.1503/cjs.008120. Print 2023 Jan-Feb.
- Results publication: PubMed 37550589Suarez-de-la-Rica A, Ripolles-Melchor J, Aldecoa C, Abad-Motos A, Ferrando C, Abad-Gurumeta A, Diaz-Almiron M, Gil-Lapetra C, Garcia-Miguel FJ, Pedregosa-Sanz A, Esteve-Perez N, Rodriguez-Jimenez R, Gimeno Fernandez P, Maseda E; POWER Study Investigators Group for the Spanish Perioperative Audit and Research Network (RedGERM-SPARN). Postoperative Critical Care Admission Was Not Associated with Improved Postoperative Outcomes in Elective Colorectal Surgery: Secondary Analysis Of POWER Trial. J Gastrointest Surg. 2023 Oct;27(10):2187-2198. doi: 10.1007/s11605-023-05780-z. Epub 2023 Aug 7.
- Results publication: PubMed 35895502Yohann A, Kayange L, Purcell L, Gallaher J, Charles A. Acute care surgery in a Malawian district hospital: Epidemiology, outcomes, and assessment of operative capacity. Trop Doct. 2023 Jan;53(1):73-80. doi: 10.1177/00494755221102226. Epub 2022 Jul 27.
- Results publication: PubMed 38789003Stahlschmidt A, Passos SC, Cardoso GR, Schuh GJ, Neto PCDS, Castro SMJ, Stefani LC. Postoperative intensive care allocation and mortality in high-risk surgical patients: evidence from a low- and middle-income country cohort. Braz J Anesthesiol. 2024 Jul-Aug;74(4):844517. doi: 10.1016/j.bjane.2024.844517. Epub 2024 May 23.
- Individual participant dataSharing planned: No. The data contains sensitive information of patients.
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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.
Norton Perez, MD principal investigator
Universidad Cooperativa de Colombia; Hospital Departamental de Villavicencio; Clínica Primavera
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Critical Illness and Postoperative Complications, run by Hospital Departamental de Villavicencio at 2 sites in Colombia.
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 3 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 21 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Colombia. 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 Norton Perez, MD (3112517471, norton.perez@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ICU mortality (time frame: 30 days). 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 NCT06731296, which also lists 10 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 21 Nov 2025.