a Comparison Between the Effects of Crystalloids and Colloids on Lung Ultrasound

NCT ID: NCT05505708

Last Updated: 2022-08-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-05
• Study Completion Date: 2023-03-31

Brief Summary

This study is designed to compare the effect of crystalloids and colloids on lung ultrasound score in preeclapmtic pregnant cases undergoing spinal anesthesia for caesarean section

Objectives:

To identify ideal fluid in order to maintain proper intravascular volume in preeclamptic patients that allows organ perfusion without causing lung congestion or pulmonary edema

Hypothesis:

the investigators hypothesize that colloids are better than crystalloids in maintaining good intravascular volume without affecting lung ultrasound score.

Detailed Description

Hypertensive disorders are the most common complications of pregnancy. They occur in 6-8% of pregnancies and account for approximately 15% of maternal deaths in the United States Pre-eclampsia is a pregnancy-specific syndrome of unknown etiology that is defined as systolic blood pressure (SBP) > 140 mmHg and/or diastolic blood pressure (DBP) > 90 mmHg presenting after 20 weeks of gestation with significant proteinuria (1) Because patients with pre-eclampsia may have significant intravascular volume deficit and reduced uteroplacental perfusion, it is prudent to administer fluids before any anesthetic interventions. (2) however it may increase their risk of developing pulmonary oedema (3) Colloids and crystalloids are two types of fluids that are used for fluid replacement, as volume expanders. Crystalloids are low-cost salt solutions (e.g. saline) with small molecules, which can move around easily when injected into the body. Colloids can be man-made (e.g. starches, dextrans, or gelatins), or naturally occurring (e.g. albumin or fresh frozen plasma (FFP)), and have bigger molecules, so stay in the blood for longer before passing to other parts of the body. (4) Women with pre-eclampsia lose protein through renal excretion and may also extravasate protein into the interstitial tissues, oncotic pressure falls because of this and the tendency to lose fluid from the intravascular space is partially determined by this mechanism. Filling the vascular space with fluid will lead to increasing peripheral oedema. Colloids will remain in the vascular compartment for longer periods than crystalloids although the loss of colloid into the interstitial tissues will also contribute to the development of oedema. Changes in capillary permeability will have an independent influence. (5) Ultrasound is now widely used in many medical specialties, being safe tool for both the parturient and the baby, ultrasound is basically used by the obstetricians in pregnant females for diagnosis of fetal presentation, placental position, fetal organs, amount of liquor and in some interventions amniocentesis. In the last 15 years, a new imaging application of sonography has emerged in the clinical arena: lung ultrasound (LUS), it can give valuable data in diagnosing and management of pneumothorax, pleural effusion, lung consolidation and pulmonary congestion. (6) The electrical cardiometry which can be used to measure and calculate hemodynamic parameters such as cardiac output, stroke volume, systemic vascular resistance, ICON (index of contractility), and thoracic fluid content. (7) In general, there is no epidemiological evidence to support the choice of colloidal solutions over crystalloids and it is not clear that colloidal solutions would be more effective and less likely to cause harm than crystalloids in preeclamptic patients. A meta-analysis was done to investigate crystalloid versus colloid resuscitation in critically ill patients however pregnant women and neonates were excluded. (8) Consequently, there is inadequate evidence supporting one view or another in the management of pre-eclampsia.

Conditions

Pulmonary Edema

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Group (V)

Group (V): will receive hydroxyethyl starch (voluven) Pfizer Inc 500ml over 30 minutes

Group Type: ACTIVE_COMPARATOR

hydroxyethyl starch in sodium chloride injection Brand Name: Voluven

Intervention Type: DRUG

(6% hydroxyethyl starch 130/0.4 in 0.9% sodium chloride injection) is a clear to slightly opalescent, colorless to slightly yellow, sterile, non-pyrogenic, isotonic solution for intravenous administration using sterile equipment.

Each 100 mL of the solution contains: 6 g of Hydroxyethyl Starch 130/0.4 and 900 mg of Sodium Chloride USP in Water for Injection USP.

In addition, sodium hydroxide, USP, or Hydrochloric acid, USP, has been added to adjust the final pH so the final solution pH is 4.0 to 5.5.

Group (R)

Group (R): will receive ringer acetate 500ml over 30 minutes

Group Type: ACTIVE_COMPARATOR

saline solution

Intervention Type: DRUG

Within each 100 mL of 0.9% sodium chloride Injection USP, there is 15.4 mEq of sodium ions and 15.4 mEq of chloride ions. Additionally, the osmolarity is 308 mOsmol/liter, and it has a pH range of 4.5 to 7

Interventions

hydroxyethyl starch in sodium chloride injection Brand Name: Voluven

(6% hydroxyethyl starch 130/0.4 in 0.9% sodium chloride injection) is a clear to slightly opalescent, colorless to slightly yellow, sterile, non-pyrogenic, isotonic solution for intravenous administration using sterile equipment.

Each 100 mL of the solution contains: 6 g of Hydroxyethyl Starch 130/0.4 and 900 mg of Sodium Chloride USP in Water for Injection USP.

In addition, sodium hydroxide, USP, or Hydrochloric acid, USP, has been added to adjust the final pH so the final solution pH is 4.0 to 5.5.

Intervention Type: DRUG

saline solution

Within each 100 mL of 0.9% sodium chloride Injection USP, there is 15.4 mEq of sodium ions and 15.4 mEq of chloride ions. Additionally, the osmolarity is 308 mOsmol/liter, and it has a pH range of 4.5 to 7

Intervention Type: DRUG

Other Intervention Names

starch; normal saline

Eligibility Criteria

Inclusion Criteria

1. Pregnant cases with preeclampsia: gestational age >32 weeks

2. Singleton pregnancy

3. Age above 18 years

Exclusion Criteria

1. Pregnant cases with preeclampsia: gestational age >32 weeks

2. Singleton pregnancy

3. Age above 18 years

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Kasr El Aini Hospital

OTHER

Sponsor Role: lead

Responsible Party

Karim mohamed abou elella

assisstant lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

abd elbar, MD

Role: PRINCIPAL_INVESTIGATOR

kasr alainy hospital

Locations

Kasr Elainy

Cairo, , Egypt

Countries

Egypt

Central Contacts

karim abou elella, master

Role: CONTACT

dr.kimo1989@gmail.com

01002290779

Other Identifiers

MD-76-2020

Identifier Type: -

Identifier Source: org_study_id