Hypotension Drug-InducedEarly Phase 1NCT03478618
Comparison of Different Protocols of Fluid Therapy in Severe Preeclamptic Patients Under Spinal Anesthesia
A Early Phase 1 study testing Lactated Ringer in people with Hypotension Drug-Induced, run by Assiut University.
Trial summary
To compare the effect of two different protocol of fluid therapy in sever preeclamptic patients under spinal anesthesia : Hemodynamic and kidney function . Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Hypotension Drug-Induced
- What is being tested?
- Lactated Ringer
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Mar 2018to Apr 2019
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- more than 36 weeks gestation
- singleton pregnant women planned for elective caesarian section
Who cannot join
- patient refusal.
- psychiatric disorders.
- parturient <36 weeks gestation, twins, abnormal cardiotocography (CTG) tracing.
- absolute contraindications for spinal anesthesia (patients refusal, raised intracranial pressure, hypovolemic states, abnormal coagulopathy).
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Comparison of Two Different Protocols of Fluid Therapy in Severe Preeclamptic Patients Under Spinal Anesthesia : Hemodynamic and Kidney Function Outcome
To compare the effect of two different protocol of fluid therapy in sever preeclamptic patients under spinal anesthesia : Hemodynamic and kidney function .
- Conditions
- Hypotension Drug-Induced
- Being tested
- Lactated Ringer
- Medical subject headings
- Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactated RingerDrug
Patients will be divided into 2 groups according to the amount of fluids received during caesarian section under spinal anesthesia.
Group (R) 30 patients will receive 15ml/kg/h lactated Ringer (LR) intraoperative. Group (L) 30 patients will receive 30ml/kg/h lactated Ringer (LR) intraoperative. blood loss will be replaced if more than 500 ml in ratio 3 ml crystalloid : 1ml blood in both groups
| Study group | Role | What they receive |
|---|---|---|
| Group R | Active comparator | 30 patients will receive 15ml/kg/h lactated Ringer (LR) intraoperative. Receives: Drug: Lactated Ringer |
| Group L | Active comparator | 30 patients will receive 30ml/kg/h lactated Ringer (LR) intraoperative. Receives: Drug: Lactated Ringer |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of hypotension
decrease in systolic blood pressure more than 20% of base line
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2018
- Study startMar 2018 (estimated)
- Primary completionMar 2019 (estimated)
- Study completionApr 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hypotension Drug-InducedStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bola Fawzi Mekhail Sedrak, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03478618
- Sponsor's protocol ID
- haemodynamics in preeclampsia
- Status last verified
- Mar 2018
- First submitted
- 21 Mar 2018
- Last updated
- 27 Mar 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ansari MR, Laghari MS, Solangi KB. Acute renal failure in pregnancy: one year observational study at Liaquat University Hospital, Hyderabad. J Pak Med Assoc. 2008 Feb;58(2):61-4.
PubMed 18333521Ganesan C, Maynard SE. Acute kidney injury in pregnancy: the thrombotic microangiopathies. J Nephrol. 2011 Sep-Oct;24(5):554-63. doi: 10.5301/JN.2011.6250.
PubMed 21240869
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Different Protocols of Fluid Therapy in Severe Preeclamptic Patients Under Spinal Anesthesia : Hemodynamic and Kidney Function Outcome
- ClinicalTrials.gov ID
- NCT03478618
- Acronym / sponsor ID
- haemodynamics in preeclampsia
- Conditions
- Hypotension Drug-Induced
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Mar 2018 (estimated)
- Primary completion
- Mar 2019 (estimated)
- Study completion
- Apr 2019 (estimated)
- First posted
- 27 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To compare the effect of two different protocol of fluid therapy in sever preeclamptic patients under spinal anesthesia : Hemodynamic and kidney function .
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group R | Active comparator | Drug: Lactated Ringer30 patients will receive 15ml/kg/h lactated Ringer (LR) intraoperative. |
| Group L | Active comparator | Drug: Lactated Ringer30 patients will receive 30ml/kg/h lactated Ringer (LR) intraoperative. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- more than 36 weeks gestation
- singleton pregnant women planned for elective caesarian section
Key exclusion criteria (4 listed)
- patient refusal.
- psychiatric disorders.
- parturient <36 weeks gestation, twins, abnormal cardiotocography (CTG) tracing.
- absolute contraindications for spinal anesthesia (patients refusal, raised intracranial pressure, hypovolemic states, abnormal coagulopathy).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lactated RingerPatients will be divided into 2 groups according to the amount of fluids received during caesarian section under spinal anesthesia. Group (R) 30 patients will receive 15ml/kg/h lactated Ringer (LR) intraoperative. Group (L) 30 patients will receive 30ml/kg/h lactated Ringer (LR) intraoperative. blood loss will be replaced if more than 500 ml in ratio 3 ml crystalloid : 1ml blood in both groups | Drug | Group L, Group R |
Primary outcome
incidence of hypotension
Time frame: 1 hour
decrease in systolic blood pressure more than 20% of base line
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2018.
- Background: PubMed 18333521Ansari MR, Laghari MS, Solangi KB. Acute renal failure in pregnancy: one year observational study at Liaquat University Hospital, Hyderabad. J Pak Med Assoc. 2008 Feb;58(2):61-4.
- Background: PubMed 21240869Ganesan C, Maynard SE. Acute kidney injury in pregnancy: the thrombotic microangiopathies. J Nephrol. 2011 Sep-Oct;24(5):554-63. doi: 10.5301/JN.2011.6250.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Lactated Ringer in people with Hypotension Drug-Induced, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zein El Abadin Zarae Hassan, PhD (01005187371, zein20002002@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of hypotension (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03478618, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2018.