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NCT Number: NCT06757985

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

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.

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

woman health hospital , Assiut university

Asyut, 71515, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

a clinically guided resuscitation protocol,

Procedure

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

a transthoracic bedside focused echocardiographic assessment

Procedure

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 outcomes

  1. SOFA score

    Time frame: 48 hours.

    The change in Sequential Organ Failure Assessment (SOFA score)

Study contacts

Contact information is provided by the study sponsor or research team.

Ghada Abo Elfadl, MD

CONTACT

[email protected]

01005802086

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jan 3, 2025
Registry last updated
Jan 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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