HypovolemiaHOOINCT06229938
Detection of Hypovolemia in the Elderly Patient Undergoing Surgery
An observational study of Hypovolemia and Perioperative/Postoperative Complications, run by Amsterdam UMC, location VUmc at 1 site in Netherlands.
Trial summary
Prospective observational study, in which the primary aim of the study is to determine the incidence of perioperative hypovolemia in the elderly patient scheduled for major surgery. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Hypovolemia, Perioperative/Postoperative Complications
- What is being tested?
- Passive leg raise manoeuvre
- How many people
- 143 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 May 2018to 25 Nov 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: 150 elderly patients aging 70 years or older admitted to the hospital for scheduled major surgery. Major surgery will be defined as an expected length of stay being at least two postoperative days as these carry the greatest complication risk, including gastro-intestinal, pulmonary, major gynecological or urological and vascular surgery.
Who may be able to join
- Informed consent
- Age 70 years or older
- Scheduled for elective surgery
- Procedures with expected postoperative stay of at least two days
Who cannot join
- Procedure in ambulatory practice
- Acute surgery
- Patients with current cardiac arrhythmias
- Symptoms of cardiovascular shock or decompensation at presentation
- Impossible to perform measurements due to patient characteristics
- Inability to comprehend patient information and consequences of the study
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Amsterdam UMC, location VUmc
Amsterdam, North Holland, 1081HV
About this study
Prospective observational study, in which the primary aim of the study is to determine the incidence of perioperative hypovolemia in the elderly patient scheduled for major surgery. Hypovolemia is defined as the presence of fluid responsiveness, which equals increase in stroke volume > 10% after a passive leg raise according to the Nexfin non-invasive cardiac output measurement.
This study aims to include 150 elderly patients aging 70 years or older undergoing scheduled major surgery. The passive leg raising test on 4 consecutive time points in the perioperative period.
Read the detailed description
Rationale:
There is currently limited evidence available on the occurrence of perioperative hypovolemia in the elderly population, and whether this hypovolemic state is related to postoperative complications in these patients. More information regarding this relationship may be valuable in strategies aiming for a reduction in postoperative complications in the elderly. In particular, postoperative complications lead to long term morbidity, decrease quality of live, increase health care costs and are the most important factor of patient survival. Therefore, the present study aims to investigate how many elderly patients suffer from hypovolemia in the perioperative period, and how this relates to postoperative complications.
Objective:
The primary aim of the study is to determine the incidence of perioperative hypovolemia in the elderly patient scheduled for major surgery. Hypovolemia is defined as the presence of fluid responsiveness, which equals increase in stroke volume > 10% after a passive leg raise according to the Nexfin non-invasive cardiac output measurement.
Study design:
Open, prospective, observational study
Study population:
150 elderly patients aging 70 years or older undergoing scheduled major surgery.
Intervention:
Passive leg raising test on 4 consecutive time points in the perioperative period
Main study endpoints:
Relative number of patients that have a change in stroke volume of more than 10% upon a passive leg raising test.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
One of the investigators will visit the ward and will use the inflatable blood pressure cuff around the index finger of the right hand. The measurement will be performed while sitting and is continued for 5 minutes after lowering the head end of the bed and raising the lower end of the bed. As the bed functions electronical the change in movement occurs slowly and without any effort. Overall discomfort associated with these tests is regarded to as minimal. There are no benefits related to participation.
- Being tested
- Passive leg raise manoeuvre
- Keywords
- Elderly
- Medical subject headings
- Hypovolemia, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Passive leg raise manoeuvreOther
Stroke volume measurements are performed with the Nexfin hemodynamic monitor and the volemic state measurement is based on the principle of the classic passive leg raise test. The Nexfin monitor (Nexfin CC, Edwards Life Sciences, the Netherlands) uses a small inflatable cuff around the index finger of the right hand, to measure the blood pressure, and uses a specific algorithm to calculate the stroke volume.
First a baseline measurement is performed during supine position while the patient is lying in bed. Next, the head end will be lowered until lying flat, and the legs will be passively raised until the lower end of the bed is 30 degrees elevated. The change in stroke volume following the passive leg raise test is used to assess fluid responsiveness. An increase of 10% indicates a fluid responsive status or hypovolemia.
| Study group | Role | What they receive |
|---|---|---|
| Elderly perioperative population | All patients included in the study (minimum 70 years of age on day of surgery) Receives: Other: Passive leg raise manoeuvre |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of hypovolemia (%)
preoperative incidence of hypovolemia (stroke volume increase of 10% or more upon a passive leg raising manoeuvre)
Measured: Preoperatively; and postoperatively (at 2, 24 and 48 hours postoperatively)
Secondary outcomes (8)
Postoperative complications
All complications (descriptive); classified conform Clavien-Dindo classification
Measured: 30 day
Postoperative mortality
mortality
Measured: 30 day
Postoperative care
Unplanned Intensive Care Unit admission (categorical: yes/no); and if applicable for how long (continuous; in days).
Measured: 30 day
Blood transfusion
Erythrocytes concentrate transfusion (continuous scale; number of units)
Measured: intra-operative (duration of surgical procedure)
Fluid administration
All fluids administered: including crystalloids, colloids, medication, all blood product (continuous scale, in mL)
Measured: intra-operative (duration of surgical procedure)
Vaso-active therapy
Use of vaso active medication, including norepinephrine; epinephrine; dobutamine; atropine; phenylephrine; ephedrine (categorical: yes/no).
Measured: intra-operative (duration of surgical procedure)
Duration of surgery
Duration of surgical procedure (continuous scale; in minutes)
Measured: intra-operative (duration of surgical procedure)
Anesthetic technique
Type of anesthesia (nominal categories; general anesthesia; spinal; epidural; or mixed)
Measured: intra-operative (duration of surgical procedure)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2024
- Study start1 May 2018
- Primary completion1 May 2020
- Study completion25 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypovolemiaStudies of the same condition, open and under way.
- More trials run by Amsterdam UMC, location VUmcThe 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
- 143 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amsterdam UMC, location VUmc
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carolien SE Bulte, Amsterdam UMC, location VUmc
- Investigators
- Carolien Bulte, Phd, Principal investigator, Amsterdam UMC, location VUmc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06229938
- Sponsor's protocol ID
- ABR NL62141.029.17
- Other IDs
- METC 2018.009
- Acronym
- HOOI
- Status last verified
- Jan 2024
- First submitted
- 14 Aug 2023
- Last updated
- 29 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Hypovolemia in the Elderly Patient Undergoing Surgery
- ClinicalTrials.gov ID
- NCT06229938
- Acronym / sponsor ID
- HOOI / ABR NL62141.029.17
- Keywords
- Elderly
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 143 participants (actual)
- Lead sponsor
- Amsterdam UMC, location VUmcUniversity, hospital or other
- Study start
- 1 May 2018 (actual)
- Primary completion
- 1 May 2020 (actual)
- Study completion
- 25 Nov 2021 (actual)
- First posted
- 29 Jan 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.
Prospective observational study, in which the primary aim of the study is to determine the incidence of perioperative hypovolemia in the elderly patient scheduled for major surgery. Hypovolemia is defined as the presence of fluid responsiveness, which equals increase in stroke volume > 10% after a passive leg raise according to the Nexfin non-invasive cardiac output measurement.
This study aims to include 150 elderly patients aging 70 years or older undergoing scheduled major surgery. The passive leg raising test on 4 consecutive time points in the perioperative period.
Detailed description
Rationale:
There is currently limited evidence available on the occurrence of perioperative hypovolemia in the elderly population, and whether this hypovolemic state is related to postoperative complications in these patients. More information regarding this relationship may be valuable in strategies aiming for a reduction in postoperative complications in the elderly. In particular, postoperative complications lead to long term morbidity, decrease quality of live, increase health care costs and are the most important factor of patient survival. Therefore, the present study aims to investigate how many elderly patients suffer from hypovolemia in the perioperative period, and how this relates to postoperative complications.
Objective:
The primary aim of the study is to determine the incidence of perioperative hypovolemia in the elderly patient scheduled for major surgery. Hypovolemia is defined as the presence of fluid responsiveness, which equals increase in stroke volume > 10% after a passive leg raise according to the Nexfin non-invasive cardiac output measurement.
Study design:
Open, prospective, observational study
Study population:
150 elderly patients aging 70 years or older undergoing scheduled major surgery.
Intervention:
Passive leg raising test on 4 consecutive time points in the perioperative period
Main study endpoints:
Relative number of patients that have a change in stroke volume of more than 10% upon a passive leg raising test.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
One of the investigators will visit the ward and will use the inflatable blood pressure cuff around the index finger of the right hand. The measurement will be performed while sitting and is continued for 5 minutes after lowering the head end of the bed and raising the lower end of the bed. As the bed functions electronical the change in movement occurs slowly and without any effort. Overall discomfort associated with these tests is regarded to as minimal. There are no benefits related to participation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Elderly perioperative population | – | Other: Passive leg raise manoeuvreAll patients included in the study (minimum 70 years of age on day of surgery) |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- 150 elderly patients aging 70 years or older admitted to the hospital for scheduled major surgery. Major surgery will be defined as an expected length of stay being at least two postoperative days as these carry the greatest complication risk, including gastro-intestinal, pulmonary, major gynecological or urological and vascular surgery.
Key inclusion criteria (4 listed)
- Informed consent
- Age 70 years or older
- Scheduled for elective surgery
- Procedures with expected postoperative stay of at least two days
Key exclusion criteria (6 listed)
- Procedure in ambulatory practice
- Acute surgery
- Patients with current cardiac arrhythmias
- Symptoms of cardiovascular shock or decompensation at presentation
- Impossible to perform measurements due to patient characteristics
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 |
|---|---|---|
| Passive leg raise manoeuvreStroke volume measurements are performed with the Nexfin hemodynamic monitor and the volemic state measurement is based on the principle of the classic passive leg raise test. The Nexfin monitor (Nexfin CC, Edwards Life Sciences, the Netherlands) uses a small inflatable cuff around the index finger of the right hand, to measure the blood pressure, and uses a specific algorithm to calculate the stroke volume. First a baseline measurement is performed during supine position while the patient is lying in bed. Next, the head end will be lowered until lying flat, and the legs will be passively raised until the lower end of the bed is 30 degrees elevated. The change in stroke volume following the passive leg raise test is used to assess fluid responsiveness. An increase of 10% indicates a fluid responsive status or hypovolemia. | Other | Elderly perioperative population |
Primary outcome
Incidence of hypovolemia (%)
Time frame: Preoperatively; and postoperatively (at 2, 24 and 48 hours postoperatively)
preoperative incidence of hypovolemia (stroke volume increase of 10% or more upon a passive leg raising manoeuvre)
8 secondary outcomes
Postoperative complications
Time frame: 30 day
Postoperative mortality
Time frame: 30 day
Postoperative care
Time frame: 30 day
Blood transfusion
Time frame: intra-operative (duration of surgical procedure)
Fluid administration
Time frame: intra-operative (duration of surgical procedure)
Vaso-active therapy
Time frame: intra-operative (duration of surgical procedure)
Duration of surgery
Time frame: intra-operative (duration of surgical procedure)
Anesthetic technique
Time frame: intra-operative (duration of surgical procedure)
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 29 Jan 2024.
- Individual participant dataSharing planned: No
Related trials for Hypovolemia
RecruitingObservational study
Comparison of PPV and LVOT VTI During Passive Leg Raising to Predict Fluid Responsiveness
Hemodynamic Instability, Hypovolemia
RecruitingObservational study
Role of End-Tidal CO2 During Passive Leg Raising to Predict Fluid Responsiveness in ICU
Circulatory Failure, Critical Illness
RecruitingPhase 4
A Study to Assess the Safety and Efficacy of Centhaquine in Hypovolemic Shock Patients
Hypovolemic Shock
Not yet recruitingObservational study
Inferior Vena Cava Versus Subclavian Vein Collapsibility for Predicting Fluid Responsiveness in Trauma Hemorrhagic Shock
Hemorrhagic Shock, Trauma
Not yet recruitingObservational study
Validation of a Wearable Bioimpedance Sensor for Hydration Monitoring
Dehydration, Hypovolemia
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.
Carolien Bulte, Phd principal investigator
Amsterdam UMC, location VUmc
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 Hypovolemia and Perioperative/Postoperative Complications, run by Amsterdam UMC, location VUmc at 1 site in Netherlands.
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 6 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 29 Jan 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 Netherlands. 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?
Incidence of hypovolemia (%) (time frame: Preoperatively; and postoperatively (at 2, 24 and 48 hours postoperatively)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Jan 2024.