Postprandial HypotensionNCT05575661
Correlation Between Postprandial Hypotension and Post-induction Hypotension in the Elderly.
An observational study of Postprandial Hypotension and Post-induction Hypotension, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
Postprandial hypotension (PPH) and post-induction hypotension (PIH) are very common in the elderly population and are associated with a variety of poor outcomes.The purpose of this study is to investigate the correlation between PPH and perioperative adverse events such as PIH in the elderly. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Postprandial Hypotension, Post-induction Hypotension
- How many people
- 121 participants
- Where
- 1 siteChina
- Study dates
- 7 Nov 2022to 30 Dec 2025
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Elderly patients scheduled for elective non-cardiac surgery under general anesthesia in Peking Union Medical College Hospital
Who may be able to join
- Elderly patients (≥ 65 years old）;
- Patients with American Society of Anesthesiologists(ASA) grade I-III;
- Patients scheduled to undergo elective non-cardiac surgery under general anesthesia, with an anticipated surgical duration of over 1 hour；
- Patients with intra-tracheal intubation following intravenous general ；anesthesia induction and maintenance；
Who cannot join
- Patients with vascular diseases such as aortic aneurysm, aortic dissection, symptomatic atherosclerotic obliterans, Buerger's disease, and Raynaud's syndrome
- Patients with secondary hypertension, including renal hypertension and endocrine hypertension.
- Patients with chronic kidney disease requiring dietary restrictions or dialysis.
- Patients with Parkinson's disease or other conditions causing tremors.
- Patients with problems related to oral food ingestion or those requiring enteral nutrition.
- Patients with difficulties in measuring the upper extremities or communication problems that would interfere with study procedures.
- Patients unable to remain in a supine position for at least 2 hours.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
About this study
Official title: Correlation Between Postprandial Hypotension and Perioperative Adverse Events Such as Post-induction Hypotension in the Elderly: a Prospective Observational Study.
Postprandial hypotension (PPH) and post-induction hypotension (PIH) are very common in the elderly population and are associated with a variety of poor outcomes.The purpose of this study is to investigate the correlation between PPH and perioperative adverse events such as PIH in the elderly.
Read the detailed description
With the deepening of the aging population in our country, the number of elderly patients undergoing surgery is also increasing. Elderly patients are at higher risk for hemodynamic instability due to organ dysfunction, decreased physiological reserve, and the coexistence of multiple chronic diseases.Postprandial hypotension (PPH) is common but often unrecognized among the elderly.PPH is defined as a fall in systolic blood pressure of >20 mm Hg, or a decrease to ≤90 mm Hg when preprandial systolic blood pressure is ≥100 mm Hg within 2 hours of a meal.The pathophysiology of PPH is not clear, the decreased cardiovascular autonomic function may play an important role. Post-induction hypotension (PIH) occurs after induction but before surgical incision and autonomic dysfunction is regarded as one of the major mechanisms.This study aims to prospectively explore the correlation between PPH and perioperative adverse events such as PIH in the elderly.
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 |
|---|---|---|
| Postprandial hypotension group | Patients who have a fall in systolic blood pressure of >20 mm Hg, or a decrease to ≤90 mm Hg when preprandial systolic blood pressure is ≥100 mm Hg within 2 hours of the lunch | |
| No postprandial hypotension group | Patients who do not meet the postprandial hypotension criteria within 2 hours of the lunch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-induction hypotension
which is defined as systolic blood pressure (SBP) <90 mm Hg or a decrease of more than 30% from baseline blood pressure, mean arterial pressure(MAP)<65 mm Hg or a decrease of more than 30% from baseline blood pressure within 20 minutes after induction or before incision.
Measured: Within 20 minutes after induction or before incision.
Secondary outcomes (4)
Postoperative complications
We will use the Clavien-Dindo system to grade postoperative complications.
Measured: Within 30 days after surgery
early intraoperative hypotension （eIOH）
which is defined asa systolic blood pressure <90 mmHg, mean arterial pressure <65 mmHg, or a decrease of more than 30% from baseline
Measured: within the first 30 minutes after the start of surgery
mortality within 30 days after surgery
we will assess the mortality by postoperative follow-up
Measured: within 30 days after surgery
12-item World Health Organization Disability Assessment Schedule 2.0 score (12-item WHODAS 2.0 score)
The World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) will be employed to evaluate postoperative functional health status. The 12-item version yields a total score ranging from 12 to 60, with higher scores indicating greater disability and poorer health outcomes.
Measured: within 180 days 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 Oct 2022
- Study start7 Nov 2022
- Primary completion30 Jul 2025
- Study completion30 Dec 2025
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 Postprandial HypotensionStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- 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
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Li Xu, M.D., Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05575661
- Sponsor's protocol ID
- I-22PJ008
- Status last verified
- Sep 2026
- First submitted
- 7 Oct 2022
- Last updated
- 21 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Li T, Zang H, Che L, Cui Q, Xu L. Correlation between postprandial hypotension and post-induction hypotension in the elderly: a protocol for a prospective cohort study. BMJ Open. 2025 May 30;15(5):e095466. doi: 10.1136/bmjopen-2024-095466.
PubMed 40447437
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Postprandial Hypotension and Perioperative Adverse Events Such as Post-induction Hypotension in the Elderly: a Prospective Observational Study.
- ClinicalTrials.gov ID
- NCT05575661
- Acronym / sponsor ID
- I-22PJ008
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 7 Nov 2022 (actual)
- Primary completion
- 30 Jul 2025 (actual)
- Study completion
- 30 Dec 2025 (actual)
- First posted
- 12 Oct 2022 (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.
Postprandial hypotension (PPH) and post-induction hypotension (PIH) are very common in the elderly population and are associated with a variety of poor outcomes.The purpose of this study is to investigate the correlation between PPH and perioperative adverse events such as PIH in the elderly.
Detailed description
With the deepening of the aging population in our country, the number of elderly patients undergoing surgery is also increasing. Elderly patients are at higher risk for hemodynamic instability due to organ dysfunction, decreased physiological reserve, and the coexistence of multiple chronic diseases.Postprandial hypotension (PPH) is common but often unrecognized among the elderly.PPH is defined as a fall in systolic blood pressure of >20 mm Hg, or a decrease to ≤90 mm Hg when preprandial systolic blood pressure is ≥100 mm Hg within 2 hours of a meal.The pathophysiology of PPH is not clear, the decreased cardiovascular autonomic function may play an important role. Post-induction hypotension (PIH) occurs after induction but before surgical incision and autonomic dysfunction is regarded as one of the major mechanisms.This study aims to prospectively explore the correlation between PPH and perioperative adverse events such as PIH in the elderly.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Postprandial hypotension group | – | –Patients who have a fall in systolic blood pressure of >20 mm Hg, or a decrease to ≤90 mm Hg when preprandial systolic blood pressure is ≥100 mm Hg within 2 hours of the lunch |
| No postprandial hypotension group | – | –Patients who do not meet the postprandial hypotension criteria within 2 hours of the lunch |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Elderly patients scheduled for elective non-cardiac surgery under general anesthesia in Peking Union Medical College Hospital
Key inclusion criteria (4 listed)
- Elderly patients (≥ 65 years old）;
- Patients with American Society of Anesthesiologists(ASA) grade I-III;
- Patients scheduled to undergo elective non-cardiac surgery under general anesthesia, with an anticipated surgical duration of over 1 hour；
- Patients with intra-tracheal intubation following intravenous general ；anesthesia induction and maintenance；
Key exclusion criteria (7 listed)
- Patients with vascular diseases such as aortic aneurysm, aortic dissection, symptomatic atherosclerotic obliterans, Buerger's disease, and Raynaud's syndrome
- Patients with secondary hypertension, including renal hypertension and endocrine hypertension.
- Patients with chronic kidney disease requiring dietary restrictions or dialysis.
- Patients with Parkinson's disease or other conditions causing tremors.
- Patients with problems related to oral food ingestion or those requiring enteral nutrition.
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
Post-induction hypotension
Time frame: Within 20 minutes after induction or before incision.
which is defined as systolic blood pressure (SBP) <90 mm Hg or a decrease of more than 30% from baseline blood pressure, mean arterial pressure(MAP)<65 mm Hg or a decrease of more than 30% from baseline blood pressure within 20 minutes after induction or before incision.
4 secondary outcomes
Postoperative complications
Time frame: Within 30 days after surgery
early intraoperative hypotension （eIOH）
Time frame: within the first 30 minutes after the start of surgery
mortality within 30 days after surgery
Time frame: within 30 days after surgery
12-item World Health Organization Disability Assessment Schedule 2.0 score (12-item WHODAS 2.0 score)
Time frame: within 180 days after surgery
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 21 Sep 2026.
- Derived from this study: PubMed 40447437Li T, Zang H, Che L, Cui Q, Xu L. Correlation between postprandial hypotension and post-induction hypotension in the elderly: a protocol for a prospective cohort study. BMJ Open. 2025 May 30;15(5):e095466. doi: 10.1136/bmjopen-2024-095466.
- Individual participant dataSharing planned: No
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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.
Li Xu, M.D. principal investigator
Peking Union Medical College Hospital
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 Postprandial Hypotension and Post-induction Hypotension, run by Peking Union Medical College Hospital at 1 site in China.
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 4 inclusion and 7 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 21 Sep 2026. 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 China. 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?
Post-induction hypotension (time frame: Within 20 minutes after induction or before incision.). 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 NCT05575661, 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 21 Sep 2026.