NCT05505708

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
44

participants targeted

Target at P50-P75 for early_phase_1

Timeline
Completed

Started Dec 2022

Shorter than P25 for early_phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 9, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 18, 2022

Completed
4 months until next milestone

Study Start

First participant enrolled

December 5, 2022

Completed
27 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2023

Completed
Last Updated

August 18, 2022

Status Verified

August 1, 2022

Enrollment Period

27 days

First QC Date

August 9, 2022

Last Update Submit

August 16, 2022

Conditions

Pulmonary Edema

Outcome Measures

Primary Outcomes (1)

  • changes in Lung ultrasound score

    Alveolo-interstitial syndrome is assessed by the measurement of multiple B-lines

    changes in lung ulrasound is measured by comparing the alvelo interstitial score at baseline (before ) receiving spinal anaesthesia then after 30 minutes

Study Arms (2)

Group (V)

ACTIVE COMPARATOR

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

Drug: hydroxyethyl starch in sodium chloride injection Brand Name: Voluven

Group (R)

ACTIVE COMPARATOR

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

Drug: saline solution

Interventions

hydroxyethyl starch in sodium chloride injection Brand Name: VoluvenDRUG

(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.

Also known as: starch
Group (V)
saline solutionDRUG

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

Also known as: normal saline
Group (R)

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Pregnant cases with preeclampsia: gestational age \>32 weeks
  • Singleton pregnancy
  • Age above 18 years

You may not qualify if:

  • Pregnant cases with preeclampsia: gestational age \>32 weeks
  • Singleton pregnancy
  • Age above 18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kasr Elainy

Cairo, Egypt

Location

MeSH Terms

Conditions

Pulmonary Edema

Interventions

Hydroxyethyl Starch DerivativesStarchSaline Solution

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Dietary CarbohydratesCarbohydratesGlucansPolysaccharidesBiopolymersPolymersMacromolecular SubstancesCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • abd elbar, MD

    kasr alainy hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

karim abou elella, master

CONTACT

01002290779dr.kimo1989@gmail.com

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assisstant lecturer

Study Record Dates

First Submitted

August 9, 2022

First Posted

August 18, 2022

Study Start

December 5, 2022

Primary Completion

January 1, 2023

Study Completion

March 1, 2023

Last Updated

August 18, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will share

No individual participant data will be shared. Results will be published by the investigators in academic journals. Sharing of generated study data will be carried out in several different ways. We plan to make our results available to researchers and potential collaborators interested

Shared Documents
STUDY PROTOCOL, CSR
Time Frame
Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis.
Access Criteria
Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information or to submit a request, please contact clinicalresearchsupportcenter@ucdenver.edu."
More information

Locations

EG(1)