Hypotension Drug-InducedEarly Phase 1NCT03465943
Different Preloads for Prevention of Hypotension in Patients Undergoing Elective CS Under Intrathecal Anesthesia
A Early Phase 1 study testing Ringer and Voluven in people with Hypotension Drug-Induced, run by Assiut University.
Trial summary
The aim of this study was to compare between crystalloid versus crystalloid and colloid combination preloads for prevention of hypotension following intrathecal anaesthesia in patients undergoing elective Caesarean section. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hypotension Drug-Induced
- What is being tested?
- Ringer and Voluven
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age : 18-40 years
- ASA 1\&2
Who cannot join
- Patients with morbid obesity.
- Pre-existing or pregnancy-induced hypertension.
- Known cardiovascular or cerebrovascular disease.
- Abnormal CTG tracing.
- Any other contraindications for intrathecal anaesthesia.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Crystalloid Versus Crystalloid and Colloid Combination Preload for Prevention of Hypotension in Patients Undergoing Elective Caesarean Section Under Intrathecal Anesthesia
The aim of this study was to compare between crystalloid versus crystalloid and colloid combination preloads for prevention of hypotension following intrathecal anaesthesia in patients undergoing elective Caesarean section.
To examine weather baseline perfusion index could predict the incidence of intrathecal-induced hypotension during Caesarean section.
Read the detailed description
Intrathecal anesthesia is the most commonly used technique for elective Caesarean section all over the world.
One of the most common complications of this technique is hypotension. It's incidence is more than 80% without any prophylactic measures, this hypotension has adverse effects on both mother ( causing nausea and vomiting ) and foetus ( causing acidosis and neurological defects ).
This complication can be managed by several ways like fluid therapy, usage of vasopressors or combination between both of them.
Among the type of fluids ( crystalloid or colloid ) it's still not known which one of them is better. Crystalloid has a short intravascular half-life because of its rapid distribution into the interstitial space. On the other hand colloid remains longer within the intravascular space.
Change in baseline peripheral vascular tone due to pregnancy may affect the degree of such hypotension. The perfusion index ( PI ) derived from a pulse oximeter has been used for assessing peripheral perfusion dynamics due to changes in peripheral vascular tone.
- Conditions
- Hypotension Drug-Induced
- Being tested
- Ringer, Voluven
- Medical subject headings
- Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RingerDrug
Also called Crystalloid
1L of Ringer's solution as a preload in one group.
VoluvenDrug
Also called Hydroxyethyl starch 6%
500 ml of voluven will be given in combination with 500 ml Ringer's solution as a preload in the other group.
| Study group | Role | What they receive |
|---|---|---|
| Ringer | Active comparator | This group will receive 1 L of Ringer's solution as a preload Receives: Drug: Ringer |
| Voluven | Active comparator | This group will receive 500 ml of 6% hydroxyethyl starch ( Voluven ) and 500 ml Ringer's solution as a preload Receives: Drug: Ringer; Drug: Voluven |
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
Secondary outcomes (3)
Perfusion index
Derived from pulse oximeter
Measured: 1 hour
Heart rate
Measured: 1 hour
Urine output
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 posted15 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, Rafeek Ramez Shawky Aziz, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03465943
- Sponsor's protocol ID
- Hypotension in elective CS
- Status last verified
- Mar 2018
- First submitted
- 3 Mar 2018
- Last updated
- 15 Mar 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ripolles Melchor J, Espinosa A, Martinez Hurtado E, Casans Frances R, Navarro Perez R, Abad Gurumeta A, Calvo Vecino JM. Colloids versus crystalloids in the prevention of hypotension induced by spinal anesthesia in elective cesarean section. A systematic review and meta-analysis. Minerva Anestesiol. 2015 Sep;81(9):1019-30. Epub 2014 Dec 11.
PubMed 25501602Ngan Kee WD. Confidential enquiries into maternal deaths: 50 years of closing the loop. Br J Anaesth. 2005 Apr;94(4):413-6. doi: 10.1093/bja/aei069. No abstract available.
PubMed 15758080
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Crystalloid Versus Crystalloid and Colloid Combination Preload for Prevention of Hypotension in Patients Undergoing Elective Caesarean Section Under Intrathecal Anesthesia
- ClinicalTrials.gov ID
- NCT03465943
- Acronym / sponsor ID
- Hypotension in elective CS
- 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
- 15 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.
The aim of this study was to compare between crystalloid versus crystalloid and colloid combination preloads for prevention of hypotension following intrathecal anaesthesia in patients undergoing elective Caesarean section.
To examine weather baseline perfusion index could predict the incidence of intrathecal-induced hypotension during Caesarean section.
Detailed description
Intrathecal anesthesia is the most commonly used technique for elective Caesarean section all over the world.
One of the most common complications of this technique is hypotension. It's incidence is more than 80% without any prophylactic measures, this hypotension has adverse effects on both mother ( causing nausea and vomiting ) and foetus ( causing acidosis and neurological defects ).
This complication can be managed by several ways like fluid therapy, usage of vasopressors or combination between both of them.
Among the type of fluids ( crystalloid or colloid ) it's still not known which one of them is better. Crystalloid has a short intravascular half-life because of its rapid distribution into the interstitial space. On the other hand colloid remains longer within the intravascular space.
Change in baseline peripheral vascular tone due to pregnancy may affect the degree of such hypotension. The perfusion index ( PI ) derived from a pulse oximeter has been used for assessing peripheral perfusion dynamics due to changes in peripheral vascular tone.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ringer | Active comparator | Drug: RingerThis group will receive 1 L of Ringer's solution as a preload |
| Voluven | Active comparator | Drug: Ringer, Drug: VoluvenThis group will receive 500 ml of 6% hydroxyethyl starch ( Voluven ) and 500 ml Ringer's solution as a preload |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Age : 18-40 years
- ASA 1\&2
Key exclusion criteria (5 listed)
- Patients with morbid obesity.
- Pre-existing or pregnancy-induced hypertension.
- Known cardiovascular or cerebrovascular disease.
- Abnormal CTG tracing.
- Any other contraindications for intrathecal anaesthesia.
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 |
|---|---|---|
| RingerAlso: Crystalloid1L of Ringer's solution as a preload in one group. | Drug | Ringer, Voluven |
| VoluvenAlso: Hydroxyethyl starch 6%500 ml of voluven will be given in combination with 500 ml Ringer's solution as a preload in the other group. | Drug | Voluven |
Primary outcome
Incidence of hypotension
Time frame: 1 hour
Decrease in systolic blood pressure more than 20% of base line
3 secondary outcomes
Perfusion index
Time frame: 1 hour
Heart rate
Time frame: 1 hour
Urine output
Time frame: 1 hour
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2018.
- Background: PubMed 25501602Ripolles Melchor J, Espinosa A, Martinez Hurtado E, Casans Frances R, Navarro Perez R, Abad Gurumeta A, Calvo Vecino JM. Colloids versus crystalloids in the prevention of hypotension induced by spinal anesthesia in elective cesarean section. A systematic review and meta-analysis. Minerva Anestesiol. 2015 Sep;81(9):1019-30. Epub 2014 Dec 11.
- Results publication: PubMed 15758080Ngan Kee WD. Confidential enquiries into maternal deaths: 50 years of closing the loop. Br J Anaesth. 2005 Apr;94(4):413-6. doi: 10.1093/bja/aei069. No abstract available.
Related trials for Hypotension Drug-Induced
RecruitingPhase 4
Premedication With Atenolol Versus Metoprolol for Controlled Hypotensive Anesthesia During Nasal Surgeries
Hypotension Drug-Induced
Not yet recruiting
Alveolar Recruitment Maneuver-Induced Hypotension: A Dynamic Consequence and Intraoperative Indicator of Fluid Responsiveness
Hypotension Drug-Induced, General Anesthesia Using Endotracheal Intubation
Not yet recruiting
Effect of Lateral Decubitus Position After Spinal Anesthesia on Hemodynamic Stability in High-Risk Geriatric Patients
Hypotension Drug-Induced, Spinal Aneshtesia
Recruiting
Hemodynamic Effects of Intravenous Paracetamol in Patients Undergoing Emergency Laparotomy
Paracetamol, Hypotension Drug-Induced
RecruitingPhase 2/3
Comparison of Supra vs Infra Inguinal Fascia Iliaca Blocks for Spinal Positioning and Analgesia in Lower Limb Surgery
Post Operative Analgesia, Bradycardia
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 Ringer and Voluven 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 5 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 15 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 Essam E. Abd El-Hakeem, PhD (01207159716, Essam1993@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 NCT03465943, 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 15 Mar 2018.