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Completed

NCT Number: NCT06229938

Detection of Hypovolemia in the Elderly Patient Undergoing Surgery

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.

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Key information

Age range

70 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Amsterdam UMC, location VUmc

Amsterdam, North Holland, 1081HV, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Passive leg raise manoeuvre

Other

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.

Primary outcomes

  1. 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)

Secondary outcomes

  1. Postoperative complications

    Time frame: 30 day

    All complications (descriptive); classified conform Clavien-Dindo classification

  2. Postoperative mortality

    Time frame: 30 day

    mortality

  3. Postoperative care

    Time frame: 30 day

    Unplanned Intensive Care Unit admission (categorical: yes/no); and if applicable for how long (continuous; in days).

  4. Blood transfusion

    Time frame: intra-operative (duration of surgical procedure)

    Erythrocytes concentrate transfusion (continuous scale; number of units)

  5. Fluid administration

    Time frame: intra-operative (duration of surgical procedure)

    All fluids administered: including crystalloids, colloids, medication, all blood product (continuous scale, in mL)

  6. Vaso-active therapy

    Time frame: intra-operative (duration of surgical procedure)

    Use of vaso active medication, including norepinephrine; epinephrine; dobutamine; atropine; phenylephrine; ephedrine (categorical: yes/no).

  7. Duration of surgery

    Time frame: intra-operative (duration of surgical procedure)

    Duration of surgical procedure (continuous scale; in minutes)

  8. Anesthetic technique

    Time frame: intra-operative (duration of surgical procedure)

    Type of anesthesia (nominal categories; general anesthesia; spinal; epidural; or mixed)

Sponsors and collaborators

Lead sponsor

Amsterdam UMC, location VUmc

Other

Registry information

Acronym: HOOI

Important dates

Study start
2018
Primary completion
2020
Study completion
2021
First posted
Jan 29, 2024
Registry last updated
Jan 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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