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临床试验/CTRI/2021/08/035506
CTRI/2021/08/035506尚未招募不适用

TO EVALUATE CENTRAL VENOUS TO ARTERIAL CO2 DIFFERENCE /ARTERIAL TO CENTRAL VENOUS O2 RATIO WITH LACTATE CLEARANCE IN PATIENTS WITH SEPTIC SHOCK

Dr Ram Manohar Lohia Institute of Medical Sciences1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2021年8月15日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
100
试验地点
1
主要终点
The relationship between the P(cv-a)CO2/D(a-cv)O2 ratio and lactate clearance

研究概览

简要总结

Aims and objectives

The present study is aimed to evaluate

1.The relationship between the P(cv-a)CO2/D(a-cv)O2 ratio and LC for 8 and 24 hours and

  1. To define a cutoff value for the P(cv-a)CO2/D(a-cv)O2 ratio to identify an 8 and 24-hour LC at 10% and 20% respectively after resuscitation

Research question

Venous-to-arterial PCO2 /arterial-venous O2 content difference and to find a correlation of the above with lactate clearance in septic shock patients.

MATERIALS AND METHODS:

The global hemodynamic, arterial, and central venous blood gas analyses will be simultaneously performed on the T0, T8, T24 (in hours)

The position of the tip of the central venous catheter in the upper part of the right atrium will be confirmed on chest radiograph before sampling

Blood gas samples will be taken anaerobically in 3-mL heparinized syringes and analyzed for blood gas and the same blood gas machines will be used to analyze the arterial and central venous blood gas samples

The pairs of arterial and central venous blood samples were withdrawn simultaneously for determination of the following variables:

PaO2

PaCO2

Central venous oxygen tension (PcvO2)

Central venous carbon dioxide tension (PcvCO2) and SaO2

The Hb and lactate level will be measured from the arterial blood

The arterial oxygen content (CaO2), central venous oxygen content (CvO2), arterio venous oxygen content difference C(a-cv)O2,

veno arterial CO2 tension difference P(cv-a)CO2 ,

P(cv-a)CO2/C(a-cv)O2 ratio, lactate clearance rate (LC)

Lactate  clearance and survival will be defined as follows:

CaO2 = (1.34 × SaO2 × Hb) + (0.003 × PaO2)

CvO2 = (1.34 × SvO2 × Hb) + (0.003 × PvO2)

C(a-cv)O2 = CaO2  - CvO2

P(cv-a)CO2 = PvCO2 - PaCO2

P(cv-a)CO2/C(a-cv)O2 ratio = (PcvCO2-PaCO2)/(CaO2 - CvO2)

LC8 rate = (T0 lactate –T8 lactate)/(T0 lactate) × 100%

LC24 rate = (T0 lactate –T24 lactate)/(T0 lactate) × 100%

LC rate =10%from T0 toT8(hrs)

LCrate= 20%fromT0toT24(hrs)

Lactate clearance and survival will be defined as follows:

CaO2 = (1.34 × SaO2 × Hb) + (0.003 × PaO2)

CvO2 = (1.34 × SvO2 × Hb) + (0.003 × PvO2)

C(a-cv)O2 = CaO2 -CvO2

P(cv-a)CO2 = PvCO2 - PaCO2

P(cv-a)CO2/C(a-cv)O2 ratio = (PvCO2 -PaCO2)/(CaO2 -CvO2)

LC8 rate = (T0 lactate –T8 lactate)/(T0 lactate) × 100%

LC24 rate = (T0 lactate –T24 lactate)/(T0 lactate) × 100%

LC rate= 10%fromT0 toT8(hrs)

LCrate= 20%fromT0toT24(hrs)

4 groups

1.LC 8A (>10%)

2.LC 8B(<10%)

3.LC 24A(>20%)

4.LC 24B(<20%)

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • Patients in septic shock
  • Consent for participation from guardian
  • Patients with central venous line insitu.

排除标准

  • Declined consent from the guardian
  • Pregnant patient
  • Patients with pre existing liver or kidney disease
  • Patients with incomplete data.

结局指标

主要结局

The relationship between the P(cv-a)CO2/D(a-cv)O2 ratio and lactate clearance

时间窗: The relationship between the P(cv-a)CO2/D(a-cv)O2 ratio and lactate clearance at baseline, 8 hours and 24 hours.

次要结局

  • To define a cut offvalue for the P(cv-a)CO2/D(a-cv)O2 ratio to identify lactate clearance at 8 & 24 hrs respectively after resuscitation(8 hrs and 24 hrs)

研究者

发起方
Dr Ram Manohar Lohia Institute of Medical Sciences
申办方类型
Research institution and hospital

研究点 (1)

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