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Completed

NCT Number: NCT03218540

Stroke Volume Variation vs Central Venous Pressure Guidance Fluid Management in Endovascular Aortic Repair

Hypothesis: Fluid management guided by stroke volume variation (SVV), compared with central venous pressure (CVP), guidance results in better clinical outcomes.

Primary outcomes: Perioperative, up to 48 h postoperative, serum lactate and creatinine level.

Methods: Adult patients undergoing endovascular aortic aneurysm repair (EVAR) will be randomized into 2 groups: SVV group managed by SVV guidance and CVP group managed by CVP guidance.

Outcome analyses: Compare serum lactate, creatinine as well as other postoperative complications between both groups.

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Key information

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Medicine, Khon Kaen University

Khon Kaen, 40002, Thailand

About this study

Objective: To compare postoperative clinical outcome in adult patient undergoing EVAR.

Primary outcome: Postoperative serum lactate and creatinine.

Secondary outcome: Postoperative complications.

Methods: Eligible patients will be randomized to 2 groups. Both groups will be managed intraoperatively in the same way, except fluid management protocol. SVV group will be managed according to stroke volume variation (SVV) protocol, i.e., control SVV 10-13% and give fluid when SVV > 13%. CVP group will be managed using central venous pressure (CVP) protocol, i.e., control CVP 8-12 mmHg and give fluid when CVP < 8 mmHg.

Outcome analyses: Postoperative serum lactate and creatinine of both groups will be compared using unpaired Student-t test. Secondary outcomes will be compared using chi-square test.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 40-80 years old
  • Patient had aortic aneurysm both thoracic and abdominal types
  • Scheduled for elective EVAR procedures
  • New York Heart Association (NYHA) or American society of Anesthesiology (ASA) classification I-III
  • Body mass index (BMI) 18-24 kg/m2
  • Provided informed consent before surgery

Exclusion criteria

  • Scheduled for emergency or redo surgery
  • Received prior fluid therapy (>2,500 ml/day over the 48 h before the surgery)
  • Presence of congenital heart disease, cardiomyopathy, rheumatic heart disease, or significant arrhythmia or cardiopulmonary dysfunction, or significant renal or liver diseases
  • Preoperative use of vasoactive drugs (e.g. digoxin, nitroglycerine, nifedipine) for ≥3 months
  • Difficulty (or contraindication to) placing a central venous catheter
  • Inability to cooperate (e.g. mental disorder, disturbance of consciousness, mental retardation)
  • Presence of blood-borne infectious disease (e.g. syphilis, acquired immunodeficiency

Treatment and study plan

Fluid management protocol

Procedure

SVV protocol: keep SVV 10-13% and give fluid when SVV > 13% CVP protocol: keep CVP 8-12 mmHG and give fluid when CVP < 8 mmHg

Primary outcomes

  1. lactate and creatinine level

    Time frame: at the end of surgery up to 48 hours

    serum lactate and creatinine level

Sponsors and collaborators

Lead sponsor

Khon Kaen University

Other

Registry information

Official study title

Directed Fluid Therapy Based on Stroke Volume Variations Improves Fluid Management in Endovascular Aortic Repair for Aortic Aneurysm Patients: a Randomized Trial

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Jul 14, 2017
Registry last updated
Aug 18, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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