Doppler Echocardiography Versus Clinical Targets Guided Therapy on the Outcome of Postpartum Septic Shock.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: a clinically guided resuscitation protocol,, a transthoracic bedside focused echocardiographic assessment.
- Who it may be relevant to
- Registry conditions: Doppler Echocardiography, Postpartum Septic Shock. Basic parameters: 18 years — 45 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Doppler Echocardiography Versus Clinical Targets Guided Therapy on the Outcome of Postpartum Septic Shock, a Randomized Controlled Trial
Overview
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
- Procedure a clinically guided resuscitation protocol,
a clinically guided resuscitation protocol, derived from EGDT and modified to match with the latest survival sepsis campaign guidelines - Procedure a 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;
Primary outcome measures
- SOFA score [Time frame: 48 hours.]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Prevention
Study locations
Egypt · 1 center
- woman health hospital , Assiut university — Asyut
Publications
- 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. PMID 25776532
- Hernandez G, Ospina-Tascon GA, Damiani LP, Estenssoro E, Dubin A, Hurtado J, Friedman G, Castro R, Alegria L, Teboul JL, Cecconi M, Ferri G, Jibaja M, Pairumani R, Fernandez P, Barahona D, Granda-Luna V, Cavalcanti AB, Bakker J; The ANDROMEDA SHOCK Investigators and the Latin America Intensive Care Network (LIVEN); Hernandez G, Ospina-Tascon G, Petri Damiani L, Estenssoro E, Dubin A, Hurtado J, Fr PMID 30772908
Identifiers
NCT: NCT06757985 · Doppler echocardiography