Balanced Crystalloids in Postpartum Hemorrhage

Impact of Balanced Crystalloids in Obstetric Hemorrhage: A Prospective Cohort Study

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.

Study Overview

• Status: Unknown
• Conditions: Postpartum Hemorrhage
• Intervention / Treatment: Drug: Lactate Ringer; Drug: Plasma-lyte

Detailed Description

Problem Statement Maternal mortality is a tragic event with great social, economic and legal impact. The incidence rate varies depending on the source, however, it covers 400 cases per 100,000 live births per year. The first cause of death in these patients is obstetric hemorrhage, which generates 150,000 deaths per year in the world. Not being outside of this situation, Bogotá presents a high number of women who present this complication, being the cause of death in 29% of cases in the years 2012 and 2013. Once this problem is identified, multiple strategies have sought to reduce maternal morbidity and mortality, one of the most influential being the "Millennium Development Goals", now called "Sustainable Development Goals". Associated with these, national and regional public policies are developed that seek to raise awareness about the importance of timely and early diagnosis, multidisciplinary and synchronous management among several health areas with the aim of preventing and treating obstetric hemorrhage to avoid fatal outcomes.

Within the prevention and management of obstetric bleeding, there are behaviors that have shown significant impact on outcomes, such as, for example, the administration of uterotonics in the active management of delivery, which reduce the risk of postpartum hemorrhage by up to 50% or the early administration of tranexamic acid, reducing mortality by 30%. However, despite these advances, a fundamental part of the initial handling of support is the volumetric resuscitation with crystalloids and in this field, although there is an indication to initiate replenishment of losses it is not clear what type of liquid to use and if any given their characteristics intrinsic can be superior to the other.

Justification In clinical practice, the goal of resuscitation is to return to cellular homeostasis. Normal saline has been used for volumetric resuscitation for more than 50 years. However, questions about its suitability have been raised given the association with negative outcomes given its composition and question whether modifications in these would bring better results. Multiple studies associated resuscitation with an unbalanced solution (normal saline) with hyperchloremic acidosis, acute kidney injury and morbidity in general, especially in the critically ill patient.

However, until now the evidence is not conclusive about whether this impact on the base acid state, hydroelectrolytic imbalance, and potential kidney injury is less with "balanced" solutions and generate better clinical results in all scenarios, surgical patients, patients and particularly in hypovolemic shock due to obstetric hemorrhage.

Research question Are there differences in the volume of fluids and blood products to be used in the outcomes of patients with obstetric hemorrhage with the use of balanced crystalloids (Lactate Ringer or Plasma-Lyte) at the Hospital Universitario Santa Fe de Bogotá during the years 2018 - 2019?

• Study Type: Observational
• Enrollment (Anticipated): 40

Contacts and Locations

Study Locations

• Colombia
  • Bogotá, Colombia, 110111
    • Recruiting
    • Hospital Universitario Fundación Santa Fé de Bogota
    • Contact: Leopoldo E Ferrer, M.D.; Phone Number: 5016 6030303; Email: lfanesthesia@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• 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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Lactate Ringer; Patients managed with Ringer Lactate	Drug: Lactate Ringer; Patients managed with Lactate Ringer and obstetric hemorrhage; Other Names: Cristalloids
Plasma-Lyte; Patients managed with Plasma-Lyte	Drug: Plasma-lyte; Patients managed with Plasma-Lyte and obstetric hemorrhage; Other Names: Balanced cristalloids

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Fundación Santa Fe de Bogota
• Investigators: Principal Investigator: Leopoldo E Ferrer, M.D., Hospital Universitario Fundación Santa Fé de Bogota

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 25, 2019
• Primary Completion (ANTICIPATED): May 30, 2020
• Study Completion (ANTICIPATED): July 30, 2020

Study Registration Dates

• First Submitted: January 25, 2019
• First Submitted That Met QC Criteria: January 30, 2019
• First Posted (ACTUAL): January 31, 2019

Study Record Updates

• Last Update Posted (ACTUAL): February 4, 2019
• Last Update Submitted That Met QC Criteria: January 31, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Pregnancy Complications; Obstetric Labor Complications; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Postpartum Hemorrhage; Pharmaceutical Solutions; Ophthalmic Solutions; Plasma-lyte 148
• Other Study ID Numbers: CCEI-9813-2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No