UndernutritionNCT06802575
The Postsurgical Pain in Elderly Patients Suffering From Undernourishment
An observational study of Undernutrition and Pain, run by Democritus University of Thrace at 1 site in Greece.
Trial summary
INTRODUCTION Undernourishment is the situation when someone does not consume all the essential nutrients for the metabolic functions of the body. It is crystal clear for clinicians that undernourishment is considered as a factor of poor clinical outcome; however, it is being underestimated. Read more about this study
- Who is it for?
- Ages 70 to 100 years
- Conditions the study is for
- Undernutrition, Pain
- How many people
- 81 participants
- Where
- 1 siteGreece
- Study dates
- 1 Apr 2020to 31 Dec 2024
- How long will I take part?
- 6 Months
- 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 70 to 100 years
- All sexes
- Older adult
Study population: Surgical patients, with nutritonal deficits or not, at least 70 years old, after sigbing consent form
Who may be able to join
- Age ≥70 years old
- consent form for the participation
- scheduled or emergent surgeries or revision of them.
Who cannot join
- Patients with psychiatric background
- cancer patients
- corticosteroid therapy or chemotherapy
- patients with chronic inflammatory diseases of the gastrointestinal system.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Nutritional Screening and Inflammation: Key Biomarkers of Postoperative Pain and Recovery in Elderly Surgical Patients
INTRODUCTION Undernourishment is the situation when someone does not consume all the essential nutrients for the metabolic functions of the body. It is crystal clear for clinicians that undernourishment is considered as a factor of poor clinical outcome; however, it is being underestimated. The prevalence of it is not the same globally because of the lack of diagnostic criteria. There have been some researchers who have suggested different prognostic and diagnostic scores and laboratory exercises and most of them are now considered reliable. With the rapid growth of elderly population, much more patients of this age group are hospitalized for scheduled or emergent operations. A big percentage suffers from nutritional deficiencies, while an operation is considered as a hypermetabolic period. This worsens the postoperative period even more because of the co-morbidities and prolongs the hospitalization, raises the number of complications and the in-hospital mortality and the health care cost. Pain is one more factor which entangles the postoperative and rehabilitation period, so acute and chronic pain should not been forgotten. There are no data available which relate the acute and chronic postoperative pain with undernourishment, while it would be interesting for us to find out if the treatment of surgical pain in the undernourished patients is efficient.
AIM In this non-interventional observational prospective study, the investigators examine the level of postoperative pain, acute or chronic, in undernourished elderly patients and also the incidence of postoperative complications and the possible hospital readmission within 30 days period from the surgical procedure in comparison with the patients with no nutritional deficiencies. The study findings will help us to provide better intraoperative management of undernourished patients in order to achieve a more advantageous postoperative result.
METHODS In this study, surgical patients with age ≥70 years old will be separated in 2 groups, after the categorization of them in undernourished or not. The investigators will include patients aged ≥70 years old that they are admitted in the hospital and will receive anesthesia either for scheduled or for emergent surgical procedure. Preoperatively, some scores and laboratory exercises will be conducted which are considered the most accepted tools for the diagnosis of undernourishment. VAS (Visual Analog Scale), MNA (Mini Nutritional Assessment tool) and NUTRIC (Nutrition Risk in the Critically Ill) scores, with the last one being the most accepted one from both the Society of Critical Care Medicine (SCCM) and American Society for Parental and Enteral Nutrition (A.S.P.E.N.) will be conducted as diagnostic tools. The investigators will assess the following preoperative laboratory exercises: Exercises for Kidney and Liver function, Electrolytes, Biomarkers of Inflammation and Adipokines. Furthermore, all patients under general anesthesia will be monitored with NOL (Nociception Level Index) monitor. Group A will be consisted of undernourished patients for scheduled or emergent surgery and Group B will be consisted of patients with normal nutritional status. First of all, the acute postoperative pain, according to VAS score, right after surgery, 24 hours postoperative and 3-7 days after (the first 7 postoperative days are considered as a hypermetabolic period) will be compared between the 2 Groups and secondly, the chronic postoperative day, according to VAS score too, 30 days after surgery and after 6 months. Moreover, the investigators will study the relationship between undernourishment and demographic factors (gender, age and smoking), functional capability in day life, morbidity according to ASA score, surgical data, postoperative complications, readmission within 30 days after discharge and mortality within the same period of time. Inclusion criteria will be the following: Age ≥70 years old, consent form for the participation, scheduled or emergent surgeries or revision of them. Exclusion criteria will be the following: Patients with psychiatric background, cancer patients, corticosteroid therapy or chemotherapy and patients with chronic inflammatory diseases of the gastrointestinal system.
- Conditions
- Undernutrition, Pain
- Medical subject headings
- Malnutrition, Pain
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation of nutritional status and postsurgical pain
The primary outcome of this study is to evaluate whether nutritional deficiencies, as identified by these scores, are associated with higher levels of acute and chronic postoperative pain
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2025
- Study start1 Apr 2020
- Primary completion31 Mar 2024
- Study completion31 Dec 2024
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 UndernutritionStudies 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
- 81 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Democritus University of Thrace
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rafail Ioannidis, Democritus University of Thrace
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06802575
- Sponsor's protocol ID
- ΔΠΘ/ΤΙΑΤΡ/35548/3207
- Status last verified
- Feb 2025
- First submitted
- 26 Jan 2025
- Last updated
- 4 Feb 2025
- Results posted
- No
Publications
Ioannidis R, Sarridou D, Tsigalou C, Bampoulas A, Chloropoulou P. Bridging the Gap: The Impact of Preoperative Nutritional Status and Inflammation in Postoperative Pain in Elderly Patients. Anesthesiol Res Pract. 2025 Aug 28;2025:6832202. doi: 10.1155/anrp/6832202. eCollection 2025.
PubMed 40917986
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutritional Screening and Inflammation: Key Biomarkers of Postoperative Pain and Recovery in Elderly Surgical Patients
- ClinicalTrials.gov ID
- NCT06802575
- Acronym / sponsor ID
- ΔΠΘ/ΤΙΑΤΡ/35548/3207
- Conditions
- Undernutrition, Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Democritus University of ThraceUniversity, hospital or other
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 31 Mar 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 31 Jan 2025 (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 Undernourishment is the situation when someone does not consume all the essential nutrients for the metabolic functions of the body. It is crystal clear for clinicians that undernourishment is considered as a factor of poor clinical outcome; however, it is being underestimated. The prevalence of it is not the same globally because of the lack of diagnostic criteria. There have been some researchers who have suggested different prognostic and diagnostic scores and laboratory exercises and most of them are now considered reliable. With the rapid growth of elderly population, much more patients of this age group are hospitalized for scheduled or emergent operations. A big percentage suffers from nutritional deficiencies, while an operation is considered as a hypermetabolic period. This worsens the postoperative period even more because of the co-morbidities and prolongs the hospitalization, raises the number of complications and the in-hospital mortality and the health care cost. Pain is one more factor which entangles the postoperative and rehabilitation period, so acute and chronic pain should not been forgotten. There are no data available which relate the acute and chronic postoperative pain with undernourishment, while it would be interesting for us to find out if the treatment of surgical pain in the undernourished patients is efficient.
AIM In this non-interventional observational prospective study, the investigators examine the level of postoperative pain, acute or chronic, in undernourished elderly patients and also the incidence of postoperative complications and the possible hospital readmission within 30 days period from the surgical procedure in comparison with the patients with no nutritional deficiencies. The study findings will help us to provide better intraoperative management of undernourished patients in order to achieve a more advantageous postoperative result.
METHODS In this study, surgical patients with age ≥70 years old will be separated in 2 groups, after the categorization of them in undernourished or not. The investigators will include patients aged ≥70 years old that they are admitted in the hospital and will receive anesthesia either for scheduled or for emergent surgical procedure. Preoperatively, some scores and laboratory exercises will be conducted which are considered the most accepted tools for the diagnosis of undernourishment. VAS (Visual Analog Scale), MNA (Mini Nutritional Assessment tool) and NUTRIC (Nutrition Risk in the Critically Ill) scores, with the last one being the most accepted one from both the Society of Critical Care Medicine (SCCM) and American Society for Parental and Enteral Nutrition (A.S.P.E.N.) will be conducted as diagnostic tools. The investigators will assess the following preoperative laboratory exercises: Exercises for Kidney and Liver function, Electrolytes, Biomarkers of Inflammation and Adipokines. Furthermore, all patients under general anesthesia will be monitored with NOL (Nociception Level Index) monitor. Group A will be consisted of undernourished patients for scheduled or emergent surgery and Group B will be consisted of patients with normal nutritional status. First of all, the acute postoperative pain, according to VAS score, right after surgery, 24 hours postoperative and 3-7 days after (the first 7 postoperative days are considered as a hypermetabolic period) will be compared between the 2 Groups and secondly, the chronic postoperative day, according to VAS score too, 30 days after surgery and after 6 months. Moreover, the investigators will study the relationship between undernourishment and demographic factors (gender, age and smoking), functional capability in day life, morbidity according to ASA score, surgical data, postoperative complications, readmission within 30 days after discharge and mortality within the same period of time. Inclusion criteria will be the following: Age ≥70 years old, consent form for the participation, scheduled or emergent surgeries or revision of them. Exclusion criteria will be the following: Patients with psychiatric background, cancer patients, corticosteroid therapy or chemotherapy and patients with chronic inflammatory diseases of the gastrointestinal system.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
Who may qualify
- Ages
- 70 to 100 years
- Sex
- All
- Age groups
- Older adult
- Study population
- Surgical patients, with nutritonal deficits or not, at least 70 years old, after sigbing consent form
Key inclusion criteria (3 listed)
- Age ≥70 years old
- consent form for the participation
- scheduled or emergent surgeries or revision of them.
Key exclusion criteria (4 listed)
- Patients with psychiatric background
- cancer patients
- corticosteroid therapy or chemotherapy
- patients with chronic inflammatory diseases of the gastrointestinal system.
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
Correlation of nutritional status and postsurgical pain
Time frame: 6 months
The primary outcome of this study is to evaluate whether nutritional deficiencies, as identified by these scores, are associated with higher levels of acute and chronic postoperative pain
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 4 Feb 2025.
- Derived from this study: PubMed 40917986Ioannidis R, Sarridou D, Tsigalou C, Bampoulas A, Chloropoulou P. Bridging the Gap: The Impact of Preoperative Nutritional Status and Inflammation in Postoperative Pain in Elderly Patients. Anesthesiol Res Pract. 2025 Aug 28;2025:6832202. doi: 10.1155/anrp/6832202. eCollection 2025.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Undernutrition and Pain, run by Democritus University of Thrace at 1 site in Greece.
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 3 inclusion and 4 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 4 Feb 2025. 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 Greece. 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?
Correlation of nutritional status and postsurgical pain (time frame: 6 months). 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 NCT06802575, 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 4 Feb 2025.