Prevalence of Hypovolemia and Heart Failure in Non-cardiac Surgery

Heart Failure Clinical Trial

Official title:

Prevalence of Hypovolemia and Heart Failure in Non-cardiac Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03349593
• Other study ID #: 2016/361-31 II
• Status: Completed
• Start date: December 1, 2017
• Est. completion date: December 30, 2019

Study information

• Verified date: December 2021
• Source: Umeå University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Prevalence of biventricular function of the heart and preoperative level of venous return is not known in non-cardiac non-morbid obese population. The aim of the study is to assess the preoperative function of the heart and status of hypovolemia on the day of surgery.

Description:

Preoperative transthoracic echocardiography (TTE) is conducted in 100 individuals. Biventricular function (i.e. systolic and diastolic properties), left ventricular filling pressures and level of venous return are assessed by TTE. Moreover high-sensitive troponine I and Nt-proBNP, ECG are collected. Multiple echocardiographic parameters will be studied for feasibility in terms of preoperative assessment of the heart.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 30, 2019
• Est. primary completion date: November 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• body mass index = 35 kg/m2, electively scheduled for breast cancer surgery, endocrinologic surgery (thyroid, parathyroid) and general abdominal surgery.

Exclusion Criteria:

• Not signed consent.

Related Conditions & MeSH terms

• Diastolic Dysfunction
• Heart Failure
• Hypovolemia
• Systolic Dysfunction
• Venous; Return (Anomaly)

Intervention

Diagnostic Test:
• Echocardiography
Preoperative transthoracic echocardiography

Locations

Country	Name	City	State
Sweden	Sunderby hospital	Luleå

Sponsors (1)

Lead Sponsor	Collaborator
Umeå University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hypovolemia	Screening of preoperative level of venous return	One hour before surgery
Primary	Heart failure	Screening of incidence of preoperative systolic and diastolic function	One hour before surgery