Detection of Hypovolemia in the Elderly Patient Undergoing Surgery

Perioperative/Postoperative Complications Clinical Trial

— HOOI  

Official title:

Detection of Hypovolemia in the Elderly Patient Undergoing Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06229938
• Other study ID #: ABR NL62141.029.17
• Secondary ID: METC 2018.009
• Status: Completed
• Start date: May 1, 2018
• Est. completion date: November 25, 2021

Study information

• Verified date: January 2024
• Source: Amsterdam UMC, location VUmc
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 143
• Est. completion date: November 25, 2021
• Est. primary completion date: May 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypovolemia
• Perioperative/Postoperative Complications
• Postoperative Complications

Intervention

Other:
• Passive leg raise manoeuvre
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.

Locations

Country	Name	City	State
Netherlands	Amsterdam UMC, location VUmc	Amsterdam	Noord-Holland

Sponsors (1)

Lead Sponsor	Collaborator
Amsterdam UMC, location VUmc

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of hypovolemia (%)	preoperative incidence of hypovolemia (stroke volume increase of 10% or more upon a passive leg raising manoeuvre)	Preoperatively; and postoperatively (at 2, 24 and 48 hours postoperatively)
Secondary	Postoperative complications	All complications (descriptive); classified conform Clavien-Dindo classification	30 day
Secondary	Postoperative mortality	mortality	30 day
Secondary	Postoperative care	Unplanned Intensive Care Unit admission (categorical: yes/no); and if applicable for how long (continuous; in days).	30 day
Secondary	Blood transfusion	Erythrocytes concentrate transfusion (continuous scale; number of units)	intra-operative (duration of surgical procedure)
Secondary	Fluid administration	All fluids administered: including crystalloids, colloids, medication, all blood product (continuous scale, in mL)	intra-operative (duration of surgical procedure)
Secondary	Vaso-active therapy	Use of vaso active medication, including norepinephrine; epinephrine; dobutamine; atropine; phenylephrine; ephedrine (categorical: yes/no).	intra-operative (duration of surgical procedure)
Secondary	Duration of surgery	Duration of surgical procedure (continuous scale; in minutes)	intra-operative (duration of surgical procedure)
Secondary	Anesthetic technique	Type of anesthesia (nominal categories; general anesthesia; spinal; epidural; or mixed)	intra-operative (duration of surgical procedure)