Doppler Echocardiography Versus Clinical Targets Guided Therapy on the Outcome of Postpartum Septic Shock.

Assiut University

Status: Not yet enrolling

Conditions: Doppler Echocardiography; Postpartum Septic Shock

Treatments: Procedure: a transthoracic bedside focused echocardiographic assessment; Procedure: a clinically guided resuscitation protocol,

Study type: Interventional

Funder types: Other

Identifiers

NCT06757985

Doppler echocardiography

Details and patient eligibility

About

Postpartum sepsis is widely known as a preventable main cause of maternal morbidity and mortality. According to the World Health Organization, approximately 11% of the estimated maternal deaths worldwide were attributed to sepsis. Recent global assessments indicate that obstetric infections rank as the third most prevalent cause of maternal death, with a prevalence mainly observed in low- and middle-income nations.

Full description

The management of septic shock is a major medical concern. Early goal-directed therapy emerged as a novel approach for reducing sepsis mortality and was incorporated into Surviving Sepsis Campaign guidelines in 2012. Early detection of sepsis, rapid initiation of antibiotics and effective resuscitation with fluids, vasopressors, and inotropes were important concerns. However, many randomized trials were done to examine the effect of EGDT on morbidity and mortality and showed that EGDT was not associated with a significant reduction in mortality in patients with septic shock compared to usual care. That it wasn't addressed in recent guidelines in 2016 and 2021.

Enrollment: 60 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• postpartum women, within 6 weeks following delivery
• meeting the third international consensus definitions for septic Shock (2016) (Sepsis-3): acute persisting hypotension requiring vasopressors to maintain mean arterial pressure (MAP) ≥ 65 mm Hg and having a serum lactate > 2 mmol/L (18 mg/dL) despite adequate volume resuscitation

Exclusion criteria

• Patient refusal
• History of any chronic cardiac disease
• Requirement for immediate surgery
• Hypotension attributable to another cause
• Do-not-resuscitate status
• Contraindication to central venous catheter placement
• Difficult transthoracic echocardiographic evaluation
• Primary cardiogenic cause of shock, instead of sepsis.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 2 patient groups

CTGT group

Experimental group

Description:

a clinically guided resuscitation protocol, derived from EGDT

Treatment:

Procedure: a clinically guided resuscitation protocol,

ECHO group

Experimental group

Description:

a transthoracic bedside focused echocardiographic assessment of the patient

Treatment:

Procedure: a transthoracic bedside focused echocardiographic assessment