Detection of Hypovolemia in the Elderly Patient Undergoing Surgery (HOOI)

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.

Study Overview

• Status: Completed
• Conditions: Hypovolemia; Perioperative/Postoperative Complications
• Intervention / Treatment: Other: Passive leg raise manoeuvre

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 Type: Observational
• Enrollment (Actual): 143

Contacts and Locations

Study Locations

• Netherlands
  • Noord-Holland
    • Amsterdam, Noord-Holland, Netherlands, 1081HV
      • Amsterdam UMC, location VUmc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Elderly perioperative population; All patients included in the study (minimum 70 years of age on day of surgery)

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative complications	All complications (descriptive); classified conform Clavien-Dindo classification	30 day
Postoperative mortality	mortality	30 day
Postoperative care	Unplanned Intensive Care Unit admission (categorical: yes/no); and if applicable for how long (continuous; in days).	30 day
Blood transfusion	Erythrocytes concentrate transfusion (continuous scale; number of units)	intra-operative (duration of surgical procedure)
Fluid administration	All fluids administered: including crystalloids, colloids, medication, all blood product (continuous scale, in mL)	intra-operative (duration of surgical procedure)
Vaso-active therapy	Use of vaso active medication, including norepinephrine; epinephrine; dobutamine; atropine; phenylephrine; ephedrine (categorical: yes/no).	intra-operative (duration of surgical procedure)
Duration of surgery	Duration of surgical procedure (continuous scale; in minutes)	intra-operative (duration of surgical procedure)
Anesthetic technique	Type of anesthesia (nominal categories; general anesthesia; spinal; epidural; or mixed)	intra-operative (duration of surgical procedure)

Collaborators and Investigators

• Sponsor: Amsterdam UMC, location VUmc
• Investigators: Principal Investigator: Carolien Bulte, Phd, Amsterdam UMC, location VUmc

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2018
• Primary Completion (Actual): May 1, 2020
• Study Completion (Actual): November 25, 2021

Study Registration Dates

• First Submitted: August 14, 2023
• First Submitted That Met QC Criteria: January 26, 2024
• First Posted (Estimated): January 29, 2024

Study Record Updates

• Last Update Posted (Estimated): January 29, 2024
• Last Update Submitted That Met QC Criteria: January 26, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Elderly
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Hypovolemia
• Other Study ID Numbers: ABR NL62141.029.17; METC 2018.009 (Other Identifier: Ethics Committee VUmc)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No