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Levosimendan for Cardiac Patients Undergoing Major Abdominal Cancer Surgeries

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ClinicalTrials.gov Identifier: NCT03557255
Recruitment Status : Completed
First Posted : June 14, 2018
Last Update Posted : June 14, 2018
Sponsor:
Information provided by (Responsible Party):
Ehab Hanafy Shaker, National Cancer Institute, Egypt

Brief Summary:
The objective of this pilot study is to evaluate the efficacy and safety of preoperative administration of levosimendan in patients with chronic heart failure scheduled for major abdominal cancer surgery assuming the reduction of both perioperative morbidity and mortality.

Condition or disease Intervention/treatment Phase
Heart Failure Drug: Levosimendan Drug: Saline Phase 2

Detailed Description:

Cardiac complications are one of the most common causes of perioperative morbidity and mortality in patients undergoing non-cardiac surgery. Heart failure (HF) is an established risk factor for postoperative cardiac complications and mortality. The risk for postoperative mortality following major non-cardiac surgery is twice as that of patients with coronary artery disease (CAD) without HF. HF occurs in 1% to 6% of patients after major surgery, the risk being higher, between 6% and 25%, in patients with pre-existing cardiac conditions such as CAD, prior HF or valvular heart disease.

Cardiovascular disease and cancer are among the leading causes of mortality worldwide. The number of patients presenting with both diseases concomitantly is likely to increase. Cardiac patients undergoing major abdominal cancer surgeries with substantial fluid shift, blood loss and severe hemodynamic instability are at higher risk for perioperative HF.Therefore, preoperative optimization of such patients is of paramount importance. Unfortunately, guidelines for the perioperative management and preparation of such patients have not been proposed. Besides, the prophylactic use of inotropic agents for preoperative optimization of patients at high risk for HF remains controversial owing to their potential to jeopardize the myocardial oxygen supply-demand balance or to induce dysrhythmias with an assumed higher mortality.

Levosimendan is a calcium sensitizer with a positive inotropic action that has been shown to safely improve cardiac performance and hemodynamics in HF patients without increasing the myocardial oxygen demand or causing dysrrhythmias. The perioperative use of levosimendan for optimization of patients with HF has been reported in few studies with promising results, mainly for cardiac patients undergoing cardiac surgeries. However, the role of levosimendan has not been thoroughly evaluated in patients with chronic heart failure (CHF) undergoing major cancer surgery.

The purpose of this prospective study is to evaluate the safety and efficacy of preoperative administration of levosimendan in patients with CHF scheduled for major abdominal cancer surgery.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Role of Preoperative Use of Levosimendan in Ischemic Cardiac Patients Undergoing Major Abdominal Cancer Surgeries: A Prospective Randomized Study
Actual Study Start Date : August 1, 2017
Actual Primary Completion Date : February 1, 2018
Actual Study Completion Date : April 23, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Active Comparator: levosimendan
Levosimendan was prepared in a concentration of 25 µg/ml and infusion was commenced at a rate of 0.1 µg/kg/minute without loading and continued for 24 hours before surgery.The dose was doubled if an increase of > 20 mmHg in systolic blood pressure (SBP) could not be obtained within 2 hours after starting the infusion. Indications for dose reduction were the development of hypotension (SBP < 80 mmHg) or tachycardia (heart rate > 120 beats/min) persisting for more than 10 minute or (premature beats in a frequency exceeding 6/min or occurrence of a significant arrhythmia occurring in runs). The infusion medication would be discontinued should such occurrences persist despite dose reduction.
Drug: Levosimendan
Preoperative 24 hours infusion of levosimendan for chronic heart failure patients prior to major abdominal cancer surgeries.
Other Name: drug group

Active Comparator: control
In the control group ,an identical saline infusion regimen was employed instead of levosimendan . Both patient and care giver were blinded for the study.
Drug: Saline
Preoperative 24 hours infusion of normal saline for chronic heart failure patients prior to major abdominal cancer surgeries.
Other Name: control group




Primary Outcome Measures :
  1. Changes in mechanical ventilation [ Time Frame: Baseline and after two weeks ]
    The total duration of postoperative ventilation in days


Secondary Outcome Measures :
  1. Changes in Ejection fraction [ Time Frame: Baseline and after one week postoperative ]
    The improvement in the ejection fraction in percentage.

  2. Changes in cardiac index [ Time Frame: Baseline and after one week postoperative ]
    The improvement in Cardiac index (Liters/minute/square meter)

  3. Changes in Stroke volume index [ Time Frame: Baseline and after one week postoperative ]
    The improvement in stroke volume index(milliliters/square meter)

  4. Patient total hospital length of stay [ Time Frame: Baseline and after two weeks postoperative ]
    Total hospital length of stay in days.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients suffering from CHF with left ventricular ejection fraction < 35%, scheduled for major abdominal cancer surgery were eligible.
  • Aged 18 to 75 years.

Exclusion criteria were :

  • restrictive or obstructive cardiomyopathy.
  • severe cardiac valvular disease.
  • history of atrial fibrillation, ventricular tachycardia or fibrillation.
  • resting systolic arterial pressure <80 mmHg.
  • second or third degree atrioventricular block.
  • Child-Pugh class C liver cirrhosis.
  • severe renal failure (defined as creatinine clearance < 30 ml/min).
  • Immediate postoperative complications such as surgical re-exploration for bleeding or suspected leak.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03557255


Locations
Egypt
Department of Anesthesia and Pain medicine.National Cancer Institute
Cairo, Egypt, 11796
Sponsors and Collaborators
National Cancer Institute, Egypt
Investigators
Principal Investigator: Ehab H Shaker, MD National Cancer Institute- Cairo University

Additional Information:
Responsible Party: Ehab Hanafy Shaker, Principal investigator, National Cancer Institute, Egypt
ClinicalTrials.gov Identifier: NCT03557255     History of Changes
Other Study ID Numbers: Ehab-Raafat.Levo
First Posted: June 14, 2018    Key Record Dates
Last Update Posted: June 14, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: the results ,conclusion and final recommendation can be shared with other researchers.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases
Simendan
Anti-Arrhythmia Agents
Cardiotonic Agents
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Protective Agents
Physiological Effects of Drugs