Balanced Crystalloids in Postpartum Hemorrhage

NCT03824743 | Unknown DMC

• 1 other identifier: CCEI-9813-2018
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Introduction: Obstetric hemorrhage is the most feared complication that can occur during childbirth and continues to be the leading cause of death in pregnant women worldwide, about 7 women die every hour in the world. This is defined as an accumulated loss of blood of more than 1000 mL with signs and symptoms of hypovolemia within 24 hours of the birth process. The main objective of resuscitation in these patients is precisely to reduce the deleterious effects that are generated from the depletion of volume and the altered capacity of oxygen transport. The current debate focuses on the safety and efficacy of each particular liquid during resuscitation and on improving long-term patient outcomes. At present, there is no conclusive evidence on the impact at the level of acid-base status, hydroelectrolytic balance and potential kidney injury with respect to the use of balanced solutions such as Plasma-Lyte or Ringer's Lactate. Objective: To determine the differences in the volume of liquids and blood products required with the use of balanced crystalloids (Ringer's Lactate or Plasma-Lyte) in patients with obstetric hemorrhage in the Hospital Universitario Fundación Santa Fe de Bogotá during 2018 - 2019. Design, Materials, and methods: Historical cohort analytical study. All patients over 18 years of age who present an obstetric hemorrhage defined as bleeding\> 1000 mL or less associated with signs or symptoms of hemodynamic instability will be included. The most important exclusion criterion is the presence of active infection at the time of the event. Patients will be divided into two groups, those who underwent hydroelectrolytic resuscitation with Plasma-Lyte and Ringer Lactate. Results and conclusions With this study, we intend to describe the differences in the base acid status measured by arterial gases in patients with obstetric hemorrhage. The aim is to find a relationship between the different groups with clinical outcomes, such as days of ICU stay and hospitalization, blood transfusion requirement, electrolyte disorders, acute kidney injury and survival.

Conditions

Postpartum Hemorrhage

Outcome Measures

Primary Outcomes (1)

• Differences in the use of fluids and blood products

  Differences in the use of fluids and blood products with the use of balanced crystalloids in obstetric hemorrhage

  2018 - 2019

Study Arms (2)

Lactate Ringer

Patients managed with Ringer Lactate

Drug: Lactate Ringer

Plasma-Lyte

Patients managed with Plasma-Lyte

Drug: Plasma-lyte

Interventions

Lactate Ringer DRUG

Patients managed with Lactate Ringer and obstetric hemorrhage

Also known as: Cristalloids

Lactate Ringer

Plasma-lyte DRUG

Patients managed with Plasma-Lyte and obstetric hemorrhage

Also known as: Balanced cristalloids

Plasma-Lyte

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Universe population: Patients with obstetric hemorrhage in the Hospital Universitario Fundación Santa Fe de Bogotá. Study population: Patients with obstetric hemorrhage at the Hospital Universitario Fundación Santa Fe de Bogotá that meet the inclusion criteria.

You may qualify if:

• Patient with a diagnosis of obstetric hemorrhage (\> 1000 mL). Over 18 years.

You may not qualify if:

• Patients with incomplete clinical history.
• Patients with active infections.
• Patients with a history of blood dyscrasias.
• Patients with known kidney disease.
• Patient with previous alteration of the acid-base status.

Sponsors & Collaborators

• Fundación Santa Fe de Bogota: lead

Study Sites (1)

Hospital Universitario Fundación Santa Fe de Bogotá

Bogotá, 110111, Colombia

RECRUITING

MeSH Terms

Conditions

Postpartum Hemorrhage

Interventions

Ringer's Lactate; Plasma-lyte 148

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Leopoldo E Ferrer, M.D.

  Hospital Universitario Fundación Santa Fe de Bogotá

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Leopoldo E Ferrer, M.D.

CONTACT

(57) 6030303; lfanesthesia@gmail.com

Guillermo A Madrid, M.D.

CONTACT

(57) 6030303; gamanesthesia@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: January 25, 2019
• First Posted: January 31, 2019
• Study Start: January 25, 2019
• Primary Completion: May 30, 2020
• Study Completion: July 30, 2020
• Last Updated: February 4, 2019

Record last verified: 2019-01

Locations

CO (1)