Clinical trial NCT06229938: Detection of Hypovolemia in the Elderly Patient Undergoing Surgery
Official title: Detection of Hypovolemia in the Elderly Patient Undergoing Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypovolemia
Perioperative/Postoperative Complications
Keywords: Elderly
Lead sponsor: Amsterdam UMC, location VUmc
Sponsor class: OTHER
First posted: 2024-01-29
Enrollment: 143
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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.

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* Informed consent
* Age 70 years or older
* Scheduled for elective surgery
* Procedures with expected postoperative stay of at least two days

Exclusion Criteria:

* 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

Primary outcomes:
measure: Incidence of hypovolemia (%)
timeFrame: Preoperatively; and postoperatively (at 2, 24 and 48 hours postoperatively)
Secondary outcomes:
measure: Postoperative complications
timeFrame: 30 day
measure: Postoperative mortality
timeFrame: 30 day
measure: Postoperative care
timeFrame: 30 day
measure: Blood transfusion
timeFrame: intra-operative (duration of surgical procedure)
measure: Fluid administration
timeFrame: intra-operative (duration of surgical procedure)
measure: Vaso-active therapy
timeFrame: intra-operative (duration of surgical procedure)
measure: Duration of surgery
timeFrame: intra-operative (duration of surgical procedure)
measure: Anesthetic technique
timeFrame: intra-operative (duration of surgical procedure)
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC, location VUmc
state: Noord-Holland
Study officials:
affiliation: Amsterdam UMC, location VUmc
name: Carolien Bulte, Phd
role: PRINCIPAL_INVESTIGATOR
References: