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Balanced Crystalloids in Postpartum Hemorrhage

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ClinicalTrials.gov Identifier: NCT03824743
Recruitment Status : Recruiting
First Posted : January 31, 2019
Last Update Posted : February 4, 2019
Sponsor:
Information provided by (Responsible Party):
Leopoldo Ferrer, Fundación Santa Fe de Bogota

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.


Condition or disease Intervention/treatment
Postpartum Hemorrhage 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?


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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Impact of Balanced Crystalloids in Obstetric Hemorrhage: A Prospective Cohort Study
Actual Study Start Date : January 25, 2019
Estimated Primary Completion Date : May 30, 2020
Estimated Study Completion Date : July 30, 2020


Group/Cohort Intervention/treatment
Lactate Ringer
Patients managed with Ringer Lactate
Drug: Lactate Ringer
Patients managed with Lactate Ringer and obstetric hemorrhage
Other Name: Cristalloids

Plasma-Lyte
Patients managed with Plasma-Lyte
Drug: Plasma-lyte
Patients managed with Plasma-Lyte and obstetric hemorrhage
Other Name: Balanced cristalloids




Primary Outcome Measures :
  1. Differences in the use of fluids and blood products [ Time Frame: 2018 - 2019 ]
    Differences in the use of fluids and blood products with the use of balanced crystalloids in obstetric hemorrhage



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.

Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03824743


Contacts
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Contact: Leopoldo E Ferrer, M.D. (57) 6030303 ext 5016 lfanesthesia@gmail.com
Contact: Guillermo A Madrid, M.D. (57) 6030303 ext 5016 gamanesthesia@gmail.com

Locations
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Colombia
Hospital Universitario Fundación Santa Fe de Bogotá Recruiting
Bogotá, Colombia, 110111
Contact: Leopoldo E Ferrer, M.D.    6030303 ext 5016    lfanesthesia@gmail.com   
Sponsors and Collaborators
Fundación Santa Fe de Bogota
Investigators
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Principal Investigator: Leopoldo E Ferrer, M.D. Hospital Universitario Fundación Santa Fe de Bogotá

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Responsible Party: Leopoldo Ferrer, Principal investigator, Fundación Santa Fe de Bogota
ClinicalTrials.gov Identifier: NCT03824743     History of Changes
Other Study ID Numbers: CCEI-9813-2018
First Posted: January 31, 2019    Key Record Dates
Last Update Posted: February 4, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Hemorrhage
Postpartum Hemorrhage
Pathologic Processes
Obstetric Labor Complications
Pregnancy Complications
Puerperal Disorders
Uterine Hemorrhage
Plasma-lyte 148
Ophthalmic Solutions
Pharmaceutical Solutions