Clinical trial NCT06757985: Doppler Echocardiography Versus Clinical Targets Guided Therapy on the Outcome of Postpartum Septic Shock.
Official title: Doppler Echocardiography Versus Clinical Targets Guided Therapy on the Outcome of Postpartum Septic Shock, a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Doppler Echocardiography
Postpartum Septic Shock
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2025-01-03
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: SOFA score
timeFrame: 48 hours.
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: woman health hospital , Assiut university
Study officials:
References:
citation: Mouncey PR, Osborn TM, Power GS, Harrison DA, Sadique MZ, Grieve RD, Jahan R, Harvey SE, Bell D, Bion JF, Coats TJ, Singer M, Young JD, Rowan KM; ProMISe Trial Investigators. Trial of early, goal-directed resuscitation for septic shock. N Engl J Med. 2015 Apr 2;372(14):1301-11. doi: 10.1056/NEJMoa1500896. Epub 2015 Mar 17.
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