Prevalence of Hypovolemia and Heart Failure in Non-cardiac Surgery

• Sponsor: Umeå University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03349593
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Actual Duration (Months): 24.9
• Patients Per Site Per Month: 4

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Hypovolemia; Heart Failure; Diastolic Dysfunction; Systolic Dysfunction; Venous; Return (Anomaly)	Diagnostic Test: Echocardiography

Detailed 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.

Study Design

• Study Type: Observational
• Actual Enrollment: 100 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Prevalence of Hypovolemia and Heart Failure in Non-cardiac Surgery
• Actual Study Start Date: Dec 1, 2017
• Actual Primary Completion Date: Nov 30, 2018
• Actual Study Completion Date: Dec 30, 2019

Outcome Measures

Primary Outcome Measures

1. Hypovolemia [One hour before surgery]

   Screening of preoperative level of venous return

2. Heart failure [One hour before surgery]

   Screening of incidence of preoperative systolic and diastolic function

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sunderby hospital	Luleå		Sweden	97180

Sponsors and Collaborators

• Umeå University

Investigators

• Principal Investigator: Tomi P Myrberg, MD PhD, Umeå University, Norrbotten county concil

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Tomi Myrberg, Principal investigator, Umeå University
• ClinicalTrials.gov Identifier: NCT03349593
• Other Study ID Numbers: 2016/361-31 II
• First Posted: Nov 21, 2017
• Last Update Posted: Jan 5, 2022
• Last Verified: Dec 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Tomi Myrberg, Principal investigator, Umeå University: Heart failure, diastolic dysfunction, venous return; Left ventricular filling pressures
• Additional relevant MeSH terms: Heart Failure; Hypovolemia

Study Results

No Results Posted as of Jan 5, 2022