跳至主要内容
临床试验/CTRI/2021/06/034184
CTRI/2021/06/034184尚未招募不适用

The incidence and risk factors for cardiovascular complications after oncosurgeries: A retrospective analysis

Regional Cancer Centre1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2021年6月15日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
200
试验地点
1
主要终点
incidence of cardiovascular complications after oncosurgeries during first thirty days postoperative period. The risk factors associated with these cardiovascular complications

研究概览

简要总结

Postoperative cardiac complicationsare major cause of morbidity and mortality in onco surgeries. Since malignancyis a  prothrombotic state the riskof  thrombotic events such as DVT(1),pulmonary embolisms and MI are high in these patients.Oncologic patientsare more prone for nutritional deficiency and cancer cachexia leading multipleelectrolyte imbalances.Age >75 yrs associated with increased risk of cardiaccomplications (2) Postoperative arrhythmias are frequent cause of morbiditywith atrial fibrillation and QT prolongation having specific relevance to theperi operative period.(3)

AIMTo estimate the incidence ofpostoperative cardiovascular complications following major cancer surgeries andto identify associated risk factors.

OBJECTIVES

â—     Primaryobjective **-**To find out theassociation with various risk factors and post op cardiac events.

â—     Secondaryobjective - To measure the incidence of electrolyte imbalances and association tocardiac events.

METHODS

â—     Study setting

Department ofAnaesthesiology, Regional Cancer Center, Thiruvananthapuram.

â—     Studypopulation

Inclusioncriteria:Allpostoperative patients above 18 yrs

Exclusion criteria:Age below 18 yrs

â—     Methodology

Study will beconducted over a period of one year by reviewing the records.Patients will be selected on basis of inclusion and exclusion criteria.

â—     Statisticalanalysis

The χ 2 testor Fisher’s exact test will be used to compare the distribution of categoricvariables, the Student t test will be used to compare continuous variables, andthe Kruskal-Wallis nonparametric test will be used for comparison of data thatdid not obey a normal distribution.

The confidenceintervals (CI) of the cumulative incidence of observed cardiac complicationswill be calculated using a binomial approach. The adjusted contribution of the different riskfactors will be estimated by Poisson regression.

REFERENCES

1.    Khushal A, Quinlan D, Alikhan R, GardnerJ, Bailey C, Cohen A. Thromboembolic disease in surgery formalignancy-rationale for prolonged thromboprophylaxis. Semin Thromb Hemost.2002 Dec;28(6):569-76. doi: 10.1055/s-2002-36701. PMID: 12536350.

2.    JoanPuig-Barberà, Soledad Márquez-Calderón, MiguelVila-Sánchez. Cardiac Complications of Major Elective Non-Cardiac Surgery:Incidence and Risk Factors.

3.    D. Sellers, C. Srinivas,G. Djaiani. Cardiovascular complications after non-cardiac surgery. Anaesthesia2018, 73 (Suppl. 1), 34–42.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 90.00 Year(s)(—)
性别
All

入选标准

  • All postoperative patients above 18 yrs.

排除标准

  • Age below 18 yrs.

结局指标

主要结局

incidence of cardiovascular complications after oncosurgeries during first thirty days postoperative period. The risk factors associated with these cardiovascular complications

时间窗: 4 weeks (30 days) after surgery

次要结局

  • To measure the incidence of electrolyte imbalances and association to cardiac events.(within 30 days (4 weeks) after surgery.)

研究者

申办方类型
Government medical college

研究点 (1)

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