Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05049941 |
| Other study ID # |
6382021 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
August 15, 2021 |
| Est. completion date |
December 15, 2021 |
Study information
| Verified date |
September 2021 |
| Source |
Minia University |
| Contact |
ahmed hassanein, MD |
| Phone |
01006946879 |
| Email |
ahmedhassanein10[@]yahoo.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
- This perspective blind randomized single center study was designed to assess central venous
and arterial gases level including P(v-a)CO2/C(a-v)O2 ratio and P(v-a)CO2 difference against
lactate clearance as an indicator of initial resuscitation in septic patients in intensive
care unit and to evaluate the success of early resuscitation protocol .this continuation of
our previous work we compared the ratio of P(v-a)CO2/C(a-v)O2 ratio against lactate
clearance(8). Mortality in the ICU in the study groups will be recorded
Description:
On ICU admission, Criteria of Systemic Inflammatory Response Criteria (SIRS) were evaluated
including: abnormal white blood cell count >12,000/ μL or <4000/ μL, heart rate >90/min,
respiratory rate >20/min or PaCO2 < 32 mmHg or abnormal body temperature >38.3 °C (100.4 °F)
or <36 °C (96.8 °F). The quick Sequential Organ Failure assessment (qSOFA) score (10)
measured at the bedside : altered level of consciousness (Glasgow Coma Scale score ≤ 13),
Systolic blood pressure < 90 mmHg and respiratory rate ≥ 22 rpm. The Acute Physiology and
Chronic Health Evaluation (APACHE II) score were collected (Knaus et al.,1985). Patients
monitoring of heart rate, pulse oximetry, invasive arterial blood pressure for measurement of
MAP, core temperature (UltraviewSL2700; Spacelaps, USA). and urine output. Laboratory
investigations includes: complete blood count, C-reactive protein, liver and renal functions,
coagulation profile, blood glucose, sodium and potassium level. All patients had jugular
central venous catheter was inserted under ultrasound guidance, and the position confirmed by
chest radiograph, then central venous pressure (CVP) was measured before starting the initial
resuscitation (T0) ansd 8 hours after resuscitation (T8). From CVP line, blood sample
analyzed by (SIEMENS RAPIDPoint® 500 blood gas machine). The following measurements were
recorded at (T0) and at (T8): Central venous oxygen saturation (ScvO2), Central venous oxygen
tension (Pvo2) and Central venous carbon dioxide tension (Pvco2). The central venous oxygen
content (Cvo2) Cvo2 = (1.34 × Svo2 × Hb) + (0.003 × Pvo2) Radial arterial canula was inserted
under ultrasound guidance to all patients and arterial blood gases (ABG) was analyzed at (T0)
and (T8) to measure: arterial oxygen tension (Pao2), arterial oxygen content (Cao2), arterial
carbon dioxide tension (Paco2), arterial oxygen saturation (Sao2.) and lactate level Cao2 =
(1.34 × Sao2 × Hb) + (0.003 × Pao2) Resuscitation Patients were randomly assigned (by
computer generated sequence) into three groups each consists of 40 patients: Group (1):
veno-arterial carbon dioxide tension / arteriovenous oxygen content P(v-a)CO2/C(a-v)O2 ratio
group; Group (2): Lactate clearance (LC) group; Lactate level was measured then LC rate was
calculated by the equation [(lactate(T0)- lactate(T8))/lactate(T0)] × 100%.
Group (3):
veno-arterial carbon dioxide tension group; P(v-a)co2 difference Measurements were obtained
at T0 (before the start of resuscitation) and at T8 (after 8 hours of the start of
resuscitation), the three groups received the same initial resuscitation protocol according
to Surviving Sepsis Campaign (9), the appropriate specimens were taken for aerobic and
anaerobic culture, empirical broad-spectrum antibiotics was given, source of infection was
controlled with removal of any old intravascular lines which may be the source of sepsis.
The early goals of resuscitation were to achieve the following: CVP of 8-12 cmH2O, MAP > 65
mm Hg, a urine output >0.5 mL/kg and Scvo2 of 70% or more, we started with 30 ml/kg
crystalloids in the first 3 hours, then we guided by hemodynamic status, if not achieved, we
were targeted by titrating vasopressors until MAP > 65 mmHg by using either norepinephrine
(0.25 mcg /kg/min increasing every 15 min) or dobutamine (2.5 mcg/min every 15 min
increased). The patients connected to mechanical ventilation if needed with appropriate
settings, with minimal dose of sedation, blood glucose controlled and anticoagulant and
Proton pump inhibitors were administrated as a prophylaxis, early enteral nutrition was
initiated, if there was no contraindications Measured data
In group (1) we prepared this measures at T0 and T8:
- The arteriovenous oxygen content difference (C(a-v)O2) C(a-v)O2 = Cao2 - Cvo2
- The venoarterial CO2 tension difference (P(v-a)CO2) P(v-a)CO2 = Pvco2 - Paco2
- P(v-a)CO2/C(a-v)O2 ratio
- (Pvco2 - Paco2)/(Cao2 - Cvo2)
