Complications; Cesarean SectionPhase 4NCT01741610
Fluid Coloading and the Incidence of Hypotension
A Phase 4 study testing Cristalloid and colloid coloading in people with Complications; Cesarean Section and Anesthesia; Adverse Effect, Spinal and Epidural, run by Cukurova University at 1 site in Turkey (Türkiye).
Trial summary
This study was conducted to evaluate the effects of rapid crystalloid (Lactated Ringer's solution) or colloid (hydroxyethyl starch; HES) cohydration with a second intravenous access line on the incidence of hypotension and ephedrine requirement during spinal anaesthesia for caesarean section. Read more about this study
- Who is it for?
- Ages 19 to 46 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Complications; Cesarean Section, Anesthesia; Adverse Effect, Spinal and Epidural, Other Fluid Overload
- What is being tested?
- Cristalloid and colloid coloading
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Oct 2008to Jun 2012
- Phase
- Phase 4
- 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 19 to 46 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- elective caesarean section under spinal anaesthesia
Who cannot join
- Significant coexisting disease such as; pre-eclampsia and hepato-renal disease,
- Pregnancy preinduced hypertension,
- Being in active labour or requiring emergency caesarean section,
- Any contraindication to regional anaesthesia such as local infection or bleeding disorders.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Rapid Fluid Administration and the Incidence of Hypotension Induced by Spinal Anaesthesia and Ephedrine Requirement: the Effect of Crystalloid Versus Colloid Coloading
This study was conducted to evaluate the effects of rapid crystalloid (Lactated Ringer's solution) or colloid (hydroxyethyl starch; HES) cohydration with a second intravenous access line on the incidence of hypotension and ephedrine requirement during spinal anaesthesia for caesarean section.
Read the detailed description
Background: Spinal anaesthesia for caesarean delivery is often associated with hypotension. This study was conducted to evaluate the effects of rapid crystalloid (Lactated Ringer's solution) or colloid (hydroxyethyl starch; HES) cohydration with a second intravenous access line on the incidence of hypotension and ephedrine requirement during spinal anaesthesia for caesarean section.
Methods: We studied 90 women with uncomplicated pregnancies undergoing elective caesarean section under spinal anaesthesia. Intravenous access was established in all with two peripheral intravenous lines, the first being used for the baseline volume infusion. Immediately after induction of spinal anaesthesia, Lactated Ringer's solution (Group L) or HES (Group C) infusions were started at the maximal possible rate via the second line in groups L and C respectively. The third group (Group E) patients received lactated Ringer's solution at a 'keep vein open' rate to maintain the double-blind nature. The incidence of hypotension, ephedrine requirements, total amount of volume and side effects were recorded.
- Conditions
- Complications; Cesarean Section, Anesthesia; Adverse Effect, Spinal and Epidural, Other Fluid Overload
- Being tested
- Cristalloid and colloid coloading
- Keywords
- Anaesthesia Spinal, Ephedrine, Fluid Therapy, Hypotension
- Medical subject headings
- Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cristalloid and colloid coloadingBiological
Also called Cristalloid coloading (Group L), Colloid coloading (Group C), No coloading (Group E)Placebo Comparator
Cristalloid coloading (Group L) Colloid coloading (Group C) No coloading (Group E)Placebo Comparator
| Study group | Role | What they receive |
|---|---|---|
| No coloading (Group E) | Placebo comparator | Placebo comparator Receives: Biological: Cristalloid and colloid coloading |
| Cristalloid (Lactated Ringer) Coloading | Active comparator | Cristalloid (Lactated Ringer's) Coloading (Group L) Receives: Biological: Cristalloid and colloid coloading |
| Colloid (HES) coloading | Active comparator | Colloid (HES) coloading (Group C) Receives: Biological: Cristalloid and colloid coloading |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rapid fluid administration and the incidence of hypotension induced by spinal anaesthesia and ephedrine requirement: the effect of crystalloid versus colloid coloading
The primary study endpoint was the ephedrine requirement (incidence of hypotension).
Measured: Four Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2012 (estimated)
- Study startOct 2008
- Primary completionAug 2011
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complications; Cesarean SectionStudies of the same condition, open and under way.
- More trials run by Cukurova 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
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cukurova University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hakki Unlugenc, Cukurova University
- Investigators
- Hakki Unlugenc, Prof Dr, Study chair, Cukurova University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01741610
- Sponsor's protocol ID
- HZLTNS97
- Status last verified
- Jan 2014
- First submitted
- 15 Nov 2012
- Last updated
- 15 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rapid Fluid Administration and the Incidence of Hypotension Induced by Spinal Anaesthesia and Ephedrine Requirement: the Effect of Crystalloid Versus Colloid Coloading
- ClinicalTrials.gov ID
- NCT01741610
- Acronym / sponsor ID
- HZLTNS97
- Conditions
- Complications; Cesarean Section, Anesthesia; Adverse Effect, Spinal and Epidural, Other Fluid Overload
- Keywords
- Anaesthesia Spinal, Ephedrine, Fluid Therapy, Hypotension
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Cukurova UniversityUniversity, hospital or other
- Study start
- Oct 2008
- Primary completion
- Aug 2011 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 5 Dec 2012 (estimated)
- 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.
This study was conducted to evaluate the effects of rapid crystalloid (Lactated Ringer's solution) or colloid (hydroxyethyl starch; HES) cohydration with a second intravenous access line on the incidence of hypotension and ephedrine requirement during spinal anaesthesia for caesarean section.
Detailed description
Background: Spinal anaesthesia for caesarean delivery is often associated with hypotension. This study was conducted to evaluate the effects of rapid crystalloid (Lactated Ringer's solution) or colloid (hydroxyethyl starch; HES) cohydration with a second intravenous access line on the incidence of hypotension and ephedrine requirement during spinal anaesthesia for caesarean section.
Methods: We studied 90 women with uncomplicated pregnancies undergoing elective caesarean section under spinal anaesthesia. Intravenous access was established in all with two peripheral intravenous lines, the first being used for the baseline volume infusion. Immediately after induction of spinal anaesthesia, Lactated Ringer's solution (Group L) or HES (Group C) infusions were started at the maximal possible rate via the second line in groups L and C respectively. The third group (Group E) patients received lactated Ringer's solution at a 'keep vein open' rate to maintain the double-blind nature. The incidence of hypotension, ephedrine requirements, total amount of volume and side effects were recorded.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| No coloading (Group E) | Placebo comparator | Biological: Cristalloid and colloid coloadingPlacebo comparator |
| Cristalloid (Lactated Ringer) Coloading | Active comparator | Biological: Cristalloid and colloid coloadingCristalloid (Lactated Ringer's) Coloading (Group L) |
| Colloid (HES) coloading | Active comparator | Biological: Cristalloid and colloid coloadingColloid (HES) coloading (Group C) |
Who may qualify
- Ages
- 19 to 46 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- elective caesarean section under spinal anaesthesia
Key exclusion criteria (4 listed)
- Significant coexisting disease such as; pre-eclampsia and hepato-renal disease,
- Pregnancy preinduced hypertension,
- Being in active labour or requiring emergency caesarean section,
- Any contraindication to regional anaesthesia such as local infection or bleeding disorders.
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 |
|---|---|---|
| Cristalloid and colloid coloadingAlso: Cristalloid coloading (Group L), Colloid coloading (Group C), No coloading (Group E)Placebo ComparatorCristalloid coloading (Group L) Colloid coloading (Group C) No coloading (Group E)Placebo Comparator | Biological | Colloid (HES) coloading, Cristalloid (Lactated Ringer) Coloading, No coloading (Group E) |
Primary outcome
Rapid fluid administration and the incidence of hypotension induced by spinal anaesthesia and ephedrine requirement: the effect of crystalloid versus colloid coloading
Time frame: Four Years
The primary study endpoint was the ephedrine requirement (incidence of hypotension).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2014.
- Cukurova UniversityLink provided by the sponsor.
Related trials for Complications; Cesarean Section
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Ultrasound Assessment Of Gastric Volume In Pregnant Women Undergoing Elective Cesarean Section
Gestational Diabetes Mellitus (GDM), Obstetric Anesthesia
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Ketamine Pharmacokinetics and Pharmacodynamics for Postpartum Depression and Pain After Cesarean Delivery
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Not yet recruiting
The Mepilex Cesarean Delivery Trial / MEPIDEL
Surgical Site Infection
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.
Hakki Unlugenc, Prof Dr study chair
Cukurova University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cristalloid and colloid coloading in people with Complications; Cesarean Section and Anesthesia; Adverse Effect, Spinal and Epidural, run by Cukurova University at 1 site in Turkey (Türkiye).
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 1 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: finished, as of the sponsor's last update on 15 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rapid fluid administration and the incidence of hypotension induced by spinal anaesthesia and ephedrine requirement: the effect of crystalloid versus colloid coloading (time frame: Four Years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Jan 2014.