Trial Outcomes & Findings for Restrictive Fluid Therapy in Severe Preeclampsia (NCT NCT02214186)
NCT ID: NCT02214186
Last Updated: 2017-03-07
Results Overview
Renal function evaluated through creatinine levels in three moments: preoperative, first and second postoperative days.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
46 participants
Primary outcome timeframe
preoperative, first and second day postoperative
Results posted on
2017-03-07
Participant Flow
We calculated the total sample size from a pilot study. Assuming a power of 80% and 95% confidence, the sample necessary to conduct the study was 21 patients in each group of interest. As we considered 10% as maximum margin of loss during follow-up, there were 23 patients enrolled in each group.
Participant milestones
| Measure |
Liberal Fluid Therapy
The liberal group will receive 1500 mL of crystalloid solution during the cesarean section. This is the non-intervention arm once that 1500 ml of crystalloid is the amount usually used during caesarean.
|
Restrictive Fluid Therapy
The restrictive group will receive 250 mL of crystalloid solution during cesarean section.
Restrictive Fluid Therapy: The intervention in this randomized clinical trial is fluid restriction during cesarean section. The restricted group will receive 250 mL of crystalloid during surgery.
|
|---|---|---|
|
Overall Study
STARTED
|
23
|
23
|
|
Overall Study
COMPLETED
|
21
|
21
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
| Measure |
Liberal Fluid Therapy
The liberal group will receive 1500 mL of crystalloid solution during the cesarean section. This is the non-intervention arm once that 1500 ml of crystalloid is the amount usually used during caesarean.
|
Restrictive Fluid Therapy
The restrictive group will receive 250 mL of crystalloid solution during cesarean section.
Restrictive Fluid Therapy: The intervention in this randomized clinical trial is fluid restriction during cesarean section. The restricted group will receive 250 mL of crystalloid during surgery.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
|
Overall Study
Protocol Violation
|
1
|
1
|
Baseline Characteristics
Restrictive Fluid Therapy in Severe Preeclampsia
Baseline characteristics by cohort
| Measure |
Liberal Fluid Therapy
n=23 Participants
The liberal group will receive 1500 mL of crystalloid solution during the cesarean section. This is the non-intervention arm once that 1500 ml of crystalloid is the amount usually used during caesarean.
|
Restrictive Fluid Therapy
n=23 Participants
The restrictive group will receive 250 mL of crystalloid solution during cesarean section.
Restrictive Fluid Therapy: The intervention in this randomized clinical trial is fluid restriction during cesarean section. The restricted group will receive 250 mL of crystalloid during surgery.
|
Total
n=46 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
31 years
STANDARD_DEVIATION 8 • n=113 Participants
|
33 years
STANDARD_DEVIATION 5 • n=163 Participants
|
32.07 years
STANDARD_DEVIATION 6.77 • n=160 Participants
|
|
Gender
Female
|
23 Participants
n=113 Participants
|
23 Participants
n=163 Participants
|
46 Participants
n=160 Participants
|
|
Gender
Male
|
0 Participants
n=113 Participants
|
0 Participants
n=163 Participants
|
0 Participants
n=160 Participants
|
|
Gestational age (weeks)
|
36.9 weeks
n=113 Participants
|
36.7 weeks
n=163 Participants
|
36.8 weeks
n=160 Participants
|
|
Body mass index (kg/m2)
|
33.78 kg/m2
STANDARD_DEVIATION 7.17 • n=113 Participants
|
31.98 kg/m2
STANDARD_DEVIATION 5.58 • n=163 Participants
|
32.88 kg/m2
STANDARD_DEVIATION 6.37 • n=160 Participants
|
|
Twin pregnancy
yes
|
2 participants
n=113 Participants
|
3 participants
n=163 Participants
|
5 participants
n=160 Participants
|
|
Twin pregnancy
no
|
21 participants
n=113 Participants
|
20 participants
n=163 Participants
|
38 participants
n=160 Participants
|
|
Chronic hypertension
yes
|
11 participants
n=113 Participants
|
9 participants
n=163 Participants
|
20 participants
n=160 Participants
|
|
Chronic hypertension
no
|
12 participants
n=113 Participants
|
14 participants
n=163 Participants
|
26 participants
n=160 Participants
|
|
Previous preeclampsia
yes
|
9 participants
n=113 Participants
|
11 participants
n=163 Participants
|
20 participants
n=160 Participants
|
|
Previous preeclampsia
no
|
14 participants
n=113 Participants
|
12 participants
n=163 Participants
|
26 participants
n=160 Participants
|
|
Diabetes Mellitus
yes
|
9 participants
n=113 Participants
|
5 participants
n=163 Participants
|
14 participants
n=160 Participants
|
|
Diabetes Mellitus
no
|
14 participants
n=113 Participants
|
18 participants
n=163 Participants
|
32 participants
n=160 Participants
|
|
Systolic blood pressure (mmHg)
|
161 mmHg
STANDARD_DEVIATION 17 • n=113 Participants
|
170 mmHg
STANDARD_DEVIATION 20 • n=163 Participants
|
165.5 mmHg
STANDARD_DEVIATION 18.5 • n=160 Participants
|
|
Diastolic blood pressure (mmHg)
|
100.05 mmHg
STANDARD_DEVIATION 11.75 • n=113 Participants
|
104.80 mmHg
STANDARD_DEVIATION 15.75 • n=163 Participants
|
102.42 mmHg
STANDARD_DEVIATION 13.75 • n=160 Participants
|
PRIMARY outcome
Timeframe: preoperative, first and second day postoperativePopulation: Were included in the analysis the patients who violated the protocol and lost follow-up (intention to treat analysis)
Renal function evaluated through creatinine levels in three moments: preoperative, first and second postoperative days.
Outcome measures
| Measure |
Liberal Fluid Therapy
n=23 Participants
The liberal group will receive 1500 mL of crystalloid solution during the cesarean section. This is the non-intervention arm once that 1500 ml of crystalloid is the amount usually used during caesarean.
|
Restrictive Fluid Therapy
n=23 Participants
The restrictive group will receive 250 mL of crystalloid solution during cesarean section.
Restrictive Fluid Therapy: The intervention in this randomized clinical trial is fluid restriction during cesarean section. The restricted group will receive 250 mL of crystalloid during surgery.
|
|---|---|---|
|
Renal Function in Severe Preeclampsia With Restrictive Fluid Therapy
Creatinine preoperative
|
0.69 mg/dl
Interval 0.55 to 0.83
|
0.73 mg/dl
Interval 0.55 to 0.83
|
|
Renal Function in Severe Preeclampsia With Restrictive Fluid Therapy
Creatinine 1st post-operative
|
0.99 mg/dl
Interval 0.8 to 1.22
|
0.93 mg/dl
Interval 0.76 to 1.25
|
|
Renal Function in Severe Preeclampsia With Restrictive Fluid Therapy
Creatinine 2nd post-operative
|
0.96 mg/dl
Interval 0.8 to 1.09
|
0.84 mg/dl
Interval 0.69 to 1.08
|
PRIMARY outcome
Timeframe: Postoperative renal dysfunctionRenal dysfunction was stratified by the Acute Kidney Injury Network (AKIN) index in three stages, in terms of creatinine increase from baseline: stage 1 included an interval of 150-200%, stage 2 200%-300%, and stage 3 more than 300% or hemodialysis
Outcome measures
| Measure |
Liberal Fluid Therapy
n=23 Participants
The liberal group will receive 1500 mL of crystalloid solution during the cesarean section. This is the non-intervention arm once that 1500 ml of crystalloid is the amount usually used during caesarean.
|
Restrictive Fluid Therapy
n=23 Participants
The restrictive group will receive 250 mL of crystalloid solution during cesarean section.
Restrictive Fluid Therapy: The intervention in this randomized clinical trial is fluid restriction during cesarean section. The restricted group will receive 250 mL of crystalloid during surgery.
|
|---|---|---|
|
Postoperative Renal Dysfunction Evaluated by the Acute Kidney Injury Network (AKIN) Index
AKIN stage I
|
7 participants
|
6 participants
|
|
Postoperative Renal Dysfunction Evaluated by the Acute Kidney Injury Network (AKIN) Index
AKIN stage II
|
2 participants
|
4 participants
|
|
Postoperative Renal Dysfunction Evaluated by the Acute Kidney Injury Network (AKIN) Index
AKIN stage III
|
1 participants
|
0 participants
|
SECONDARY outcome
Timeframe: preoperative, first and second day postoperativeEvaluate new marker of renal injury (NGAL) in the specific population of patients with severe preeclampsia, comparing the values of first and second postoperative days to baseline.
Outcome measures
| Measure |
Liberal Fluid Therapy
n=23 Participants
The liberal group will receive 1500 mL of crystalloid solution during the cesarean section. This is the non-intervention arm once that 1500 ml of crystalloid is the amount usually used during caesarean.
|
Restrictive Fluid Therapy
n=23 Participants
The restrictive group will receive 250 mL of crystalloid solution during cesarean section.
Restrictive Fluid Therapy: The intervention in this randomized clinical trial is fluid restriction during cesarean section. The restricted group will receive 250 mL of crystalloid during surgery.
|
|---|---|---|
|
Neutrophil Gelatinase-associated Lipocalin (NGAL) as New Marker of Renal Injury in Preeclampsia
NGAL preoperative
|
0.16 mg/L
Interval 0.1 to 0.2
|
0.15 mg/L
Interval 0.13 to 0.22
|
|
Neutrophil Gelatinase-associated Lipocalin (NGAL) as New Marker of Renal Injury in Preeclampsia
NGAL 1st post-operative day
|
0.18 mg/L
Interval 0.13 to 26.0
|
0.21 mg/L
Interval 0.16 to 0.29
|
|
Neutrophil Gelatinase-associated Lipocalin (NGAL) as New Marker of Renal Injury in Preeclampsia
NGAL 2nd post-operative day
|
0.15 mg/L
Interval 0.1 to 0.24
|
0.15 mg/L
Interval 0.11 to 0.22
|
SECONDARY outcome
Timeframe: preoperative, first and second day postoperativeEvaluate new marker of renal injury (Cystatin C) in the specific population of patients with severe preeclampsia, comparing the values of first and second postoperative days to baseline.
Outcome measures
| Measure |
Liberal Fluid Therapy
n=23 Participants
The liberal group will receive 1500 mL of crystalloid solution during the cesarean section. This is the non-intervention arm once that 1500 ml of crystalloid is the amount usually used during caesarean.
|
Restrictive Fluid Therapy
n=23 Participants
The restrictive group will receive 250 mL of crystalloid solution during cesarean section.
Restrictive Fluid Therapy: The intervention in this randomized clinical trial is fluid restriction during cesarean section. The restricted group will receive 250 mL of crystalloid during surgery.
|
|---|---|---|
|
Cystatin C as New Marker of Renal Injury in Preeclampsia
Cyst C 1st postoperative day
|
1.93 mg/L
Standard Deviation 0.8
|
2.03 mg/L
Standard Deviation 0.66
|
|
Cystatin C as New Marker of Renal Injury in Preeclampsia
Cyst C 2nd postoperative day
|
1.64 mg/L
Standard Deviation 0.5
|
1.72 mg/L
Standard Deviation 0.43
|
|
Cystatin C as New Marker of Renal Injury in Preeclampsia
Cyst C preoperative
|
1.73 mg/L
Standard Deviation 0.6
|
1.99 mg/L
Standard Deviation 0.61
|
SECONDARY outcome
Timeframe: Proteinuria in severe pre-eclampsia in in pre-operative and post-operative periodProteinuria in severe pre-eclampsia submitted to cesarean section under different regimes of hydration. Analyses in pre-operative and post-operative period.
Outcome measures
| Measure |
Liberal Fluid Therapy
n=23 Participants
The liberal group will receive 1500 mL of crystalloid solution during the cesarean section. This is the non-intervention arm once that 1500 ml of crystalloid is the amount usually used during caesarean.
|
Restrictive Fluid Therapy
n=23 Participants
The restrictive group will receive 250 mL of crystalloid solution during cesarean section.
Restrictive Fluid Therapy: The intervention in this randomized clinical trial is fluid restriction during cesarean section. The restricted group will receive 250 mL of crystalloid during surgery.
|
|---|---|---|
|
Proteinuria in Severe Pre-eclampsia Submitted to Cesarean Section Under Different Regimes of Hydration
Proteinuria pre-operative
|
0.46 g/dl
Interval 0.32 to 1.71
|
2.62 g/dl
Interval 0.8 to 9.6
|
|
Proteinuria in Severe Pre-eclampsia Submitted to Cesarean Section Under Different Regimes of Hydration
Proteinuria 1st post-operative day
|
0.15 g/dl
Interval 0.1 to 0.88
|
0.40 g/dl
Interval 0.28 to 0.58
|
|
Proteinuria in Severe Pre-eclampsia Submitted to Cesarean Section Under Different Regimes of Hydration
Proteinuria 2nd post-operative day
|
0.20 g/dl
Interval 0.1 to 0.48
|
0.45 g/dl
Interval 0.1 to 2.23
|
SECONDARY outcome
Timeframe: preoperative, first and second day postoperativeCompare platelets count in the restrictive and liberal groups during the first and second post-operative days.
Outcome measures
| Measure |
Liberal Fluid Therapy
n=23 Participants
The liberal group will receive 1500 mL of crystalloid solution during the cesarean section. This is the non-intervention arm once that 1500 ml of crystalloid is the amount usually used during caesarean.
|
Restrictive Fluid Therapy
n=23 Participants
The restrictive group will receive 250 mL of crystalloid solution during cesarean section.
Restrictive Fluid Therapy: The intervention in this randomized clinical trial is fluid restriction during cesarean section. The restricted group will receive 250 mL of crystalloid during surgery.
|
|---|---|---|
|
Platelets in Restrictive Fluid Management of Severe Preeclampsia
Platelets preoperative
|
194400 thrombocytes/mm3
Standard Deviation 77867
|
207941 thrombocytes/mm3
Standard Deviation 71371
|
|
Platelets in Restrictive Fluid Management of Severe Preeclampsia
Platelets 1st postoperative day
|
183250 thrombocytes/mm3
Standard Deviation 83234
|
201118 thrombocytes/mm3
Standard Deviation 61687
|
|
Platelets in Restrictive Fluid Management of Severe Preeclampsia
Platelets 2nd postoperative day
|
192850 thrombocytes/mm3
Standard Deviation 80692
|
221824 thrombocytes/mm3
Standard Deviation 62925
|
SECONDARY outcome
Timeframe: preoperative, first and second day postoperativePopulation: The values are expressed in seconds and presented as a ration (INR) with control patients.
Compare International Normalized Ratio (INR) of Prothrombin Time (PT) in the restrictive and liberal groups in preoperative, first and second day postoperative. PT is expressed in seconds and the entered values represented the INR of PT among study participants and a control population.
Outcome measures
| Measure |
Liberal Fluid Therapy
n=23 Participants
The liberal group will receive 1500 mL of crystalloid solution during the cesarean section. This is the non-intervention arm once that 1500 ml of crystalloid is the amount usually used during caesarean.
|
Restrictive Fluid Therapy
n=23 Participants
The restrictive group will receive 250 mL of crystalloid solution during cesarean section.
Restrictive Fluid Therapy: The intervention in this randomized clinical trial is fluid restriction during cesarean section. The restricted group will receive 250 mL of crystalloid during surgery.
|
|---|---|---|
|
International Normalized Ratio (INR) of Prothrombin Time (PT) in Restrictive Fluid Management of Severe Preeclampsia During Cesarean Section
PT/INR preoperative
|
1.00 ratio
Interval 0.95 to 1.1
|
0.95 ratio
Interval 0.95 to 0.98
|
|
International Normalized Ratio (INR) of Prothrombin Time (PT) in Restrictive Fluid Management of Severe Preeclampsia During Cesarean Section
PT/INR first post-operative day
|
1.03 ratio
Interval 0.95 to 1.09
|
0.95 ratio
Interval 0.95 to 0.99
|
|
International Normalized Ratio (INR) of Prothrombin Time (PT) in Restrictive Fluid Management of Severe Preeclampsia During Cesarean Section
PT/INR seconde post-operative day
|
1.0 ratio
Interval 0.97 to 1.07
|
0.95 ratio
Interval 0.95 to 0.95
|
SECONDARY outcome
Timeframe: preoperative, first and second day postoperativePopulation: The values are expressed in seconds and presented as a ration (R) with control patients.
Compare activated partial thromboplastin time (APPT) and relation with control (R) in the restrictive and liberal groups. APPT is a laboratory test that evaluates the efficiency of the intrinsic pathway of coagulation. The unit of measure is seconds and the results are presented as relation (R) with control.
Outcome measures
| Measure |
Liberal Fluid Therapy
n=23 Participants
The liberal group will receive 1500 mL of crystalloid solution during the cesarean section. This is the non-intervention arm once that 1500 ml of crystalloid is the amount usually used during caesarean.
|
Restrictive Fluid Therapy
n=23 Participants
The restrictive group will receive 250 mL of crystalloid solution during cesarean section.
Restrictive Fluid Therapy: The intervention in this randomized clinical trial is fluid restriction during cesarean section. The restricted group will receive 250 mL of crystalloid during surgery.
|
|---|---|---|
|
Activated Partial Thromboplastin Time in Restrictive Fluid Management of Severe Preeclampsia During Cesarean Section
APPT/R preoperative
|
0.98 ratio
Standard Deviation 0.13
|
1.01 ratio
Standard Deviation 0.08
|
|
Activated Partial Thromboplastin Time in Restrictive Fluid Management of Severe Preeclampsia During Cesarean Section
APPT/R 1st post-operative day
|
1.07 ratio
Standard Deviation 0.10
|
1.03 ratio
Standard Deviation 0.10
|
|
Activated Partial Thromboplastin Time in Restrictive Fluid Management of Severe Preeclampsia During Cesarean Section
APPT/R 2nd post-operative day
|
1.07 ratio
Standard Deviation 0.13
|
1.01 ratio
Standard Deviation 0.07
|
OTHER_PRE_SPECIFIED outcome
Timeframe: urine output during cesarean section (an average of 60 minutes)Urine output during cesarean section in severe pre-eclampsia under two different regimes of hydration (restrictive and liberal)
Outcome measures
| Measure |
Liberal Fluid Therapy
n=23 Participants
The liberal group will receive 1500 mL of crystalloid solution during the cesarean section. This is the non-intervention arm once that 1500 ml of crystalloid is the amount usually used during caesarean.
|
Restrictive Fluid Therapy
n=23 Participants
The restrictive group will receive 250 mL of crystalloid solution during cesarean section.
Restrictive Fluid Therapy: The intervention in this randomized clinical trial is fluid restriction during cesarean section. The restricted group will receive 250 mL of crystalloid during surgery.
|
|---|---|---|
|
Urine Output During Cesarean Section in Severe Pre-eclampsia
|
116 ml/h
Interval 69.0 to 191.0
|
80 ml/h
Interval 37.0 to 110.0
|
Adverse Events
Liberal Fluid Therapy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Restrictive Fluid Therapy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
M.D. Wallace Andrino da Silva
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
Phone: +551126616787
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place