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

Doppler Echocardiography Versus Clinical Targets Guided Therapy on the Outcome of Postpartum Septic Shock, a Randomized Controlled Trial

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06757985
Enrollment
60
Registered
2025-01-03
Start date
2024-12-30
Completion date
2026-11-30
Last updated
2025-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Doppler Echocardiography, Postpartum Septic Shock

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.

Interventions

PROCEDUREa clinically guided resuscitation protocol,

a clinically guided resuscitation protocol, derived from EGDT and modified to match with the latest survival sepsis campaign guidelines

PROCEDUREa transthoracic bedside focused echocardiographic assessment

a transthoracic bedside focused echocardiographic assessment of the patient will be done, as a baseline ECHO in a three-step approach to monitor hemodynamics using Logiq P7, S5-1 ECHO probe;

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
SOFA score48 hours.The change in Sequential Organ Failure Assessment (SOFA score)

Countries

Egypt

Contacts

Primary ContactGhada Abo Elfadl, MD
ghadafadl77@gmail.com01005802086

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026