Hemodynamic InstabilityNCT07804706
Preoperative Neutrophil-to-Albumin Ratio and Post-Induction Hemodynamic Vulnerability in Major Oncologic Surgery
An observational study of Hemodynamic Instability and Post-induction Hypotension (PIH), run by Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
This prospective observational study aims to evaluate whether the preoperative neutrophil percentage-to-albumin ratio (NPAR) is associated with post-induction hemodynamic vulnerability in adult patients undergoing elective major oncologic surgery under general anesthesia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemodynamic Instability, Post-induction Hypotension (PIH)
- How many people
- 200 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2026to 15 Dec 2026
- Phase
- Observational
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will consist of adult patients aged 18 years or older who are scheduled to undergo elective major oncologic surgery under general anesthesia. Eligible participants must have available preoperative complete blood count and serum albumin measurements and undergo standard intraoperative hemodynamic monitoring. Patients will be enrolled consecutively at the study center. Individuals undergoing emergency surgery or presenting with preoperative hemodynamic instability, vasopressor or inotropic support, sepsis or active infection, hematologic malignancy, advanced cardiac, renal, or hepatic failure, pregnancy, or missing laboratory data will be excluded.
Who may be able to join
- Age 18 years or older
- Scheduled for elective major oncologic surgery
- Undergoing surgery under general anesthesia
- Availability of preoperative complete blood count and serum albumin -measurements
- Standard hemodynamic monitoring
- Provision of written informed consent for participation in the study
Who cannot join
- Age younger than 18 years
- Emergency surgery
- Preoperative hemodynamic instability
- Preoperative vasopressor or inotropic support
- Sepsis or active infection
- Hematologic malignancy
Show all 9Show fewer
- Advanced cardiac, renal, or hepatic failure
- Pregnancy
- Missing preoperative laboratory data -Inability to complete the 20-minute post-induction evaluation period-
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Dr. Abdurrahman Yurtaslan Ankara Oncology Hospital
Ankara, Yeni̇mahalle
Mustafa Kemal Şahin, +905075800976, mksahin@msn.com
About this study
Official title: Preoperative Neutrophil Percentage-to-Albumin Ratio as a Predictor of Post-Induction Hemodynamic Vulnerability in Major Oncologic Surgery
This prospective observational study aims to evaluate whether the preoperative neutrophil percentage-to-albumin ratio (NPAR) is associated with post-induction hemodynamic vulnerability in adult patients undergoing elective major oncologic surgery under general anesthesia.
NPAR will be calculated from routine preoperative laboratory results by dividing the neutrophil percentage by the serum albumin level. No additional laboratory tests, medications, invasive procedures, or changes in anesthesia management will be performed for the purposes of the study.
Read more
Demographic characteristics, preoperative laboratory values, anesthetic data, and hemodynamic measurements will be recorded prospectively. Hemodynamic status will be evaluated during the period between induction of general anesthesia and surgical incision, with a maximum observation period of 20 minutes. Vasopressor use and administered doses will also be recorded.
The study will assess the ability of preoperative NPAR to identify patients who may be more susceptible to early hemodynamic instability following induction of general anesthesia.
Read the detailed description
This is a prospective, observational, non-interventional study involving adult patients undergoing elective major oncologic surgery under general anesthesia. The study is designed to evaluate the relationship between the preoperative neutrophil percentage-to-albumin ratio (NPAR) and post-induction hemodynamic vulnerability.
A total of 220 patients are planned to be enrolled using consecutive sampling. Eligible participants will be adults aged 18 years or older who are scheduled for elective major oncologic surgery under general anesthesia, have available preoperative complete blood count and serum albumin measurements, and undergo standard hemodynamic monitoring.
NPAR will be calculated by dividing the preoperative neutrophil percentage by the serum albumin concentration in g/dL. Demographic characteristics, ASA physical status, comorbidities, preoperative laboratory values, baseline hemodynamic measurements, induction-related data, intraoperative fluid administration, and vasopressor use and doses will be recorded prospectively.
Hemodynamic measurements will be evaluated from induction of general anesthesia until surgical incision, with a maximum observation period of 20 minutes. Participants will be classified according to the presence or absence of post-induction hemodynamic vulnerability.
The study will not alter routine anesthetic or surgical management. No additional medication, laboratory test, invasive procedure, or treatment modification will be performed for research purposes. Anesthetic agents, fluid therapy, and vasopressor administration will be determined by the responsible anesthesia team according to routine clinical practice.
The predictive performance of NPAR will be evaluated using receiver operating characteristic curve analysis and the area under the curve. Multivariable logistic regression analysis will be used to examine the association between NPAR and post-induction hemodynamic vulnerability while accounting for relevant clinical variables.
- Keywords
- Neutrophil Percentage-to-Albumin Ratio, Post-Induction Hypotension, Hemodynamic Vulnerability, Major Oncologic Surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Major Oncologic Surgery Cohort | Adult patients undergoing elective major oncologic surgery under general anesthesia will be prospectively enrolled. Preoperative neutrophil percentage-to-albumin ratio (NPAR) will be calculated from routine laboratory measurements. Hemodynamic data will be recorded from induction of general anesthesia until surgical incision, for a maximum of 20 minutes, to evaluate post-induction hemodynamic vulnerability. No research-specific intervention or modification of routine anesthetic management will be performed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of Post-Induction Hemodynamic Vulnerability
Post-induction hemodynamic vulnerability will be defined as the occurrence of at least one mean arterial pressure (MAP) measurement ≤65 mmHg after induction of general anesthesia and before surgical incision. MAP will be assessed using standard intraoperative hemodynamic monitoring.
Measured: From induction of general anesthesia to surgical incision, up to 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2026
- Study start1 Sep 2026
- Primary completion1 Dec 2026 (estimated)
- Study completion15 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Hemodynamic InstabilityStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mustafa Kemal ŞAHİN, Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07804706
- Sponsor's protocol ID
- 2026-08/185
- Status last verified
- Sep 2026
- First submitted
- 1 Sep 2026
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared. Study data will be collected and analyzed in accordance with institutional ethical and confidentiality requirements, and participant information will be kept confidential and anonymized for analysis and reporting.
Publications
Gabay C, Kushner I. Acute-phase proteins and other systemic responses to inflammation. N Engl J Med. 1999 Feb 11;340(6):448-54. doi: 10.1056/NEJM199902113400607. No abstract available.
PubMed 9971870Maheshwari K, Turan A, Mao G, Yang D, Niazi AK, Agarwal D, Sessler DI, Kurz A. The association of hypotension during non-cardiac surgery, before and after skin incision, with postoperative acute kidney injury: a retrospective cohort analysis. Anaesthesia. 2018 Oct;73(10):1223-1228. doi: 10.1111/anae.14416. Epub 2018 Aug 24.
PubMed 30144029Bijker JB, van Klei WA, Kappen TH, van Wolfswinkel L, Moons KG, Kalkman CJ. Incidence of intraoperative hypotension as a function of the chosen definition: literature definitions applied to a retrospective cohort using automated data collection. Anesthesiology. 2007 Aug;107(2):213-20. doi: 10.1097/01.anes.0000270724.40897.8e.
PubMed 17667564