Detection of Hypovolemia in the Elderly Patient Undergoing Surgery

NCT06229938 | Completed

• 2 other identifiers: ABR NL62141.029.17METC 2018.009
• Study Type: observational
• Target: 143
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypovolemia; Perioperative/Postoperative Complications

Keywords

Elderly

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Postoperative complications

  30 day

• Postoperative mortality

  30 day

• Postoperative care

  30 day

• Blood transfusion

  intra-operative (duration of surgical procedure)

• Fluid administration

  intra-operative (duration of surgical procedure)

Study Arms (1)

Elderly perioperative population

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

Other: Passive leg raise manoeuvre

Interventions

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.

Elderly perioperative population

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Amsterdam UMC, location VUmc: lead

Study Sites (1)

Amsterdam UMC, location VUmc

Amsterdam, North Holland, 1081HV, Netherlands

Location

MeSH Terms

Conditions

Hypovolemia; Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Carolien Bulte, Phd

  Amsterdam UMC, location VUmc

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: August 14, 2023
• First Posted: January 29, 2024
• Study Start: May 1, 2018
• Primary Completion: May 1, 2020
• Study Completion: November 25, 2021
• Last Updated: January 29, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)