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Completed

NCT Number: NCT06784570

Impact of Perioperative Levosimendan on Patients Undergoing Cardiac Surgery With Low Ejection Fraction

to compar levosemindan to other cardiac intropic medications that strengthen the heart in diffrent common adult heart surgery with patients with low ejection fraction(weak heart)

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Key information

Conditions

Cardiac Surgery Low Ejection Fraction

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

cardiothorathic surgery department -faculty of medecine-zagazig univeristy-Egypt

Zagazig, Sharqia Province, 44519, Egypt

About this study

in this study show the effect of levosemindan use during coronary artery surgery ,heart valve surgery and combined coronary and valve surgery in comparison to other traditional medications with patients with low ejection fraction(weak heart)

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Valve surgery
  • CABG surgery,
  • combined surgery
  • all patients Ejection Fraction less than 35 ٪ -

Exclusion criteria

  • Patients age ≤ 20-70 < years
  • Aortic and redo surgery
  • any patients with Ejection Fraction more than 35 ٪ -

Treatment and study plan

levosemindan

Drug

In common practice the loading dose is omitted as it is associated with hypotension.9 Usual dose range: 0.05 to 0.2 microg/kg/min. Dose based on actual body weight up to a maximum of 120 kg.5 Commence infusion at 0.05 microg/kg/min. If the initial rate is tolerated, consider increasing the maintenance rate to 0.1 microg/kg/min after 60 minutes. If the patient remains haemodynamically stable, further increase the dose to 0.2 microg/kg/min for the remainder of the infusion.

adrenaline,noreadrenaline,dopamine and doputamine

Drug

adrenaline:*4 9 %$ 0 ****8*4* 9 : ,- 4 - *4 9 * C % F*4 9 9 9 noreadrenaline:# *4 9 C % 9 F 9 9 *4* Q*4 9 9 dopamine:9 * C % 9 F 9 9 ) * 9 9 dobutamine:9 * C % F 9 9 9 * 9 9

Primary outcomes

  1. death through day 30,

    Time frame: 1 month (no scale for measurement as death may occured due to multible causes that be difficult to be identified and measured )

    death occured either intraoperative , ICU, ward or after discharge to home within month of the day of the surgery

  2. Renal-replacement therapy

    Time frame: 1 month

    included haemodialysis, peritoneal dialysis, or continuous Veno venous haemodialysis(indicated when serum creatinine above 2.0 mg/dl or an increase of 50% above baseline value)

  3. Perioperative myocardial infarction

    Time frame: 5 days

    defined as a creatine kinase MB level of more than 100 ng per millilitre or a level that was more than 10 times the upper limit of the normal range specified at the local laboratory, regardless of changes on the electrocardiogram, or a creatine kinase MB level that was more than 50 ng per millilitre or a level that was more than 5 times the upper limit of the normal range with new Q waves that were more than 30 msec in duration in two contiguous leads or new left bundle-branch block

  4. Intra Aortic Ballon Pumb insertion

    Time frame: 5 days(no scale for measurement )

    it consisidered to be one of the ventricular assissted device that need to be inserted in post cardiac surgery shocked patiients that not respond heamdynamically to highest doses of cardiac intropes

Sponsors and collaborators

Lead sponsor

Zagazig University

Other Gov

Registry information

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Jan 20, 2025
Registry last updated
Jan 20, 2025

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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