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Sodium sulfate 9 g/m\^2 combined with 0.9% natrium chloride 150 ml were instilled in 20 min as the time when HIPEC with cisplatin was beginning. After that, sodium sulfate 12 g/m\^2 combined with 0.9% natrium chloride 1000 ml was pumped for 6 h .

hydration: On the day of surgery, the day of HIPEC, and 24 hours after HIPEC, daily intravenous rehydration should be performed using natrium chloride, glucose chloride or potassium chloride. The amount of fluid to be replenished should not be less than 3000 milliliters.

hydration:On the day of surgery, the day of HIPEC, and 24 hours after HIPEC, daily intravenous rehydration should be performed using natrium chloride, glucose chloride or potassium chloride. The amount of fluid to be replenished should not be less than 3000 milliliters.

Sodium thiosulfate has previously been reported to reduce the incidence of acute kidney injury after HIPEC with cisplatin, but this finding has not been confirmed in a high-level study.

Sodium Sulfate

On the day of surgery, the day of HIPEC, and 24 hours after HIPEC, daily intravenous rehydration should be performed using natrium chloride, glucose chloride or potassium chloride. The amount of fluid to be replenished should not be less than 3000 milliliters.

Hydration

Infuse cisplatin (75mg/m\^2) at 43℃ through the two drainage tubes placed in the upper abdomen, using the two drainage tubes placed in the lower abdomen as the effluent tubes, with an infusion time of 60-90 minutes and an infusion rate of 500-600 mL/min. The first HIPEC should be performed within 24-48 hours after cytoreductive surgery. The second HIPEC should be performed 24 hours after the completion of the first HIPEC. Intravenous sedatives such as dexmedetomidine or propofol at 2-6 ml/h should be administered during HIPEC treatment with continuous intravenous infusion by a pump，or intramuscular injection of 50 mg of pethidine.

Jing Li, Doctor

Yuting Lai, Undergraduate

Ovarian cancer is the most lethal malignancy of the female genital tract. Cytoreductive surgery combined with chemotherapy is the primary treatment for ovarian cancer, and radical tumor resection is an important means to improve the prognosis. However, even after complete tumor resection, 75% of patients with ovarian cancer still recur within 3 years after the initial treatment and eventually die from recurrence. In ovarian cancer, the lesions are located primarily in the peritoneal cavity. High-grade evidence demonstrates that the use of intraperitoneal hyperthermic chemotherapy (HIPEC) with cisplatin after cytoreductive surgery significantly improves the outcome in some patients with ovarian cancer. Currently, this is the only non-pharmacologic treatment that reduces both the risk of recurrence and death from ovarian cancer with a multi treatment. However, HIPEC with cisplatin can lead to acute kidney injury, and a serious complication that can seriously affect the short and long-term prognosis of patients. Sodium thiosulfate has previously been reported to reduce the incidence of acute kidney injury after HIPEC with cisplatin, but this finding has not been confirmed in a high-level study. Therefore, we propose a multi-center, prospective, open-label, randomized, controlled trial including 110 patients with ovarian cancer who received HIPEC with cisplatin, to evaluate whether sodium thiosulfate combined with hydration (55 patients in the trial group) can reduce the incidence of acute kidney injury after HIPEC with cisplatin compared with hydration alone (55 patients in the control group), and to provide high-level evidence for the rationale of using sodium thiosulfate for nephrotoxicity relief in cisplatin HIPEC.

Patients were randomly assigned to treatment group or control group by block randomisation in a 1:1 ratio.

Treatment group: Receive HIPEC using sodium thiouracil and hydration Control group: Receive HIPEC only using hydration.

Effect of Sodium Thiosulfate on Nephrotoxicity of Cisplatin Intraperitoneal Heat-perfusion Chemotherapy

Effect of Sodium Thiosulfate on Nephrotoxicity of Cisplatin Intraperitoneal Heat-perfusion Chemotherapy: a Multi-center Prospective Randomized Controlled Trial.

To determine whether the use of sodium sulfate combined with hydration reduces the incidence of acute kidney injury (KDIGO criteria grade 1-3) effectively in the intention to treat population compared with hydration alone in patients receiving HIPEC with cisplatin (75mg/m\^2,43 °C,90 minutes) according to creatinine levels and 24-hour urine.

To determine whether the use of sodium sulfate combined with hydration reduces the incidence of chronic kidney injury effectively in the intention to treat population compared with hydration alone in patients receiving HIPEC with cisplatin (75mg/m\^2,43 °C,90 minutes) according to creatinine levels.

To investigate adverse events associated with sodium sulfate. The Adverse events were evaluated and graded according to CTCAE5.0

Time from randomization to relapse or death. The diagnosis of disease recurrence includes CA125 more than two times the minimum value, as specified by the Gynecologic Cancer International Collaborative Group (GCIG), or according to the RECIST v1.1 criteria. Any one of the above two criteria is met first, then the tumor is recurrent.

Yunnan Cancer Hospital

Qilu Hospital of Shandong University

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Nutritional and Metabolic Diseases

Dehydration

Water-Electrolyte Imbalance

Metabolic Diseases

Group 1: 1,000 ml of normal saline (0.9% sodium chloride) parenterally over 4 hours daily

Group 2: Lower Amount of Normal Saline (salt water); 100 ml of normal saline (0.9% sodium chloride) parenterally over 4 hours daily.

1,000 ml of normal saline (0.9% sodium chloride) parenterally over 4 hours daily.

Saline

100 ml of normal saline (0.9% sodium chloride) parenterally over 4 hours daily.

Eduardo Bruera, MD

The goal of this clinical research study is to learn whether being hydrated (given liquids) through a catheter in a vein or in the tissue under the skin can improve symptoms of dehydration.

Objectives:

1.1 Determine whether parenteral hydration is superior to placebo in improving symptoms associated with dehydration (such as fatigue, myoclonus, sedation, and hallucinations) in advanced cancer patients receiving hospice care.

1.2 Determine whether parenteral hydration is superior to placebo in delaying the onset or reducing the severity of delirium in patients with advanced cancer receiving hospice care.

1.3 Describe the meaning patients and primary caregivers attribute to dehydration and re-hydration at the end of patient's lives.

For Caregivers:

Symptoms of dehydration may include fatigue, muscle contractions, the need for sedation (calming medication), and hallucinations (where something is sensed that is not actually there). Hydration allows the body to get rid of the waste products from medications and other chemicals. When the fluid levels in the body are increased, the brain function may directly improve.

If the patient under your care is found to be eligible to take part in this study, he or she will be randomly assigned (as in the toss of the coin) to one of 2 groups. Participants in Group 1 will receive normal saline (salt water) once a day. Participants in Group 2 will receive a lower amount of normal saline once a day. This lower amount is small enough to be considered a placebo. Doctors call something a placebo if it looks like the substance being tested but has no active ingredients (or in this case, few active ingredients).

Both you and the patient will be asked to complete a number of questionnaires at the beginning of the study, on Days 1-7, and then every 3-5 days after that. Your questionnaires will ask about the feelings you may have about hydration and the care that you are providing to the patient. Each day's questionnaires will take about 30 minutes.

Both you and the patient will also be interviewed by researchers at the beginning of the study and on Day 4 (+/- 2 days). The interviews will include questions about what it has been like for the patient to get fluids, whether the fluid was more like food or medicine, whether the patient has ever gotten dehydrated, and how you manage the patient's care. The interviews should each take about 30 minutes. The interviews in this study will be audio taped so the information can be studied by researchers. Only the research staff will listen to the audio tape of the interviews.

If the patient goes off study, your participation in the study will be over.

This is an investigational study. Up to 150 patients and 150 caregivers will take part in this study. All will be enrolled at M. D. Anderson.

For Patients:

Before you can start treatment on this study, you will have "screening tests." These tests will help the doctor decide if you are eligible to take part in this study. You will be asked to complete a questionnaire. It will ask questions about your cancer diagnoses, the medications you are taking, and the symptoms you are having. The questionnaire also asks about your memory of being dehydrated, what it was like for you to get fluids, how you manage your care, and whether the fluid was more like food or medicine. It should take about 30 minutes to complete.

Both you and your caregiver will also be interviewed by researchers. There will be questions about what it has been like for you to get fluids, whether the fluid was more like food or medicine, and whether you have ever gotten dehydrated. Each interview should take about 30 minutes. The interviews in this study will be audio taped so the information can be studied by researchers.

The study staff will also check you for symptoms of muscle contraction, one of the signs of dehydration. The study staff will videotape your face, arms, hands, legs and toes for a total 3-5 minutes on Days 1, 4, and 7, and then every 3-5 days after that.

As part of the screening tests, you will also have blood drawn (about 2 teaspoons) for routine tests. You will be asked questions about your ability to perform daily activities (performance status evaluation). You will be asked about any side effects you may have, including muscle contractions. You will also be asked to list any pain medications or other medications that you take.

If you are found to be eligible to take part in this study, you will be randomly assigned (as in the toss of the coin) to one of two groups. Participants in Group 1 will receive normal saline (salt water) once a day. Participants in Group 2 will receive a lower amount of normal saline once a day. This lower amount is small enough to be considered a placebo. Doctors call something a placebo if it looks like the substance being tested but has no active ingredients (or in this case, few active ingredients). You will have an equal chance of being placed in either group. Neither you nor any of the medical staff or researchers on this study will know which dose you are receiving.

The research nurse will ask you to complete several questionnaires that ask questions about dehydration and the symptoms you may have experienced, including fatigue. The questionnaires will be completed on Days 1-7, and then every 3-5 days after that. In total, each day's questionnaires should take about 30 minutes. Your caregiver will also be asked about his or her memory of your dehydration. On Day 7, you will have blood drawn (about 2 teaspoons) for routine tests.

Both you and your caregiver will also be interviewed by researchers on Day 4 (+/- 2 days), and then every 3-5 days after that. The interviews will be like the ones at screening.

Starting on Day 1 of the study, you will receive saline through a catheter in a vein (over 4 hours) every day. If you already have a central venous catheter, you will receive the saline through that catheter. If you do not have a central venous catheter, the saline will be infused under the skin. Either way, the infusion will last about 4 hours.

During each infusion, an infusion research nurse will check to make sure that the saline is given properly. This nurse will know which treatment group you have been assigned to.

Every day, the research nurse will ask you about the dehydration and any side effects you may have. Every day, the research nurse will also check the place where the infusion is given to make sure there is no infection.

On Days 1-7 and then every 3-5 days, the research nurse will also check for any dehydration symptoms including the need for sedation, any restless feelings or actions, and/or muscle contractions. You will have a performance status evaluation daily. On Days 1-7, the research nurse will ask about any pain medications or other medications that you have taken.

Every day, 2 hours \[+/- 3 hours\] after the infusion ends, you will also be checked by an assessment research nurse who will not know which treatment group you are in. The assessment research nurse will ask about any symptoms you may have. The study staff will also check you for symptoms of muscle contraction, one of the signs of dehydration. The study staff will videotape your face, arms, hands, legs and toes for a total 3-5 minutes on Days 1, 4, and 7, and then every 3-5 days after that.

You may remain on study to receive the daily infusions for as long as you are benefitting up to Day 14 \[+/- 3 days\]. On Day 14 \[+/- 3 days\] you will be taken off study, and you will have off study assessments, which include questions about your symptoms including fatigue, performance status, medications you are taking, and dehydration symptoms. If intolerable side effects occur, you will be taken off study and given appropriate medical care. If you wish to continue receiving hydration fluids after you are taken off study \[Day 14 +/- 3 days\], you may discuss this option with your attending hospice physician. You may receive a liter of normal saline each day under the skin. Treatment will be given by hospice nurse. Fluid will be provided to you free of charge.

This is an investigational study. Up to 150 patients and 150 caregivers will take part in this study. All will be enrolled at M. D. Anderson.

Parenteral Hydration in Advanced Cancer Patients

Parenteral Hydration in Advanced Cancer Patients - A Randomized Controlled Trial

Symptom burden, assessed using the Edmonton Symptom assessment scale, which has been validated in the cancer population. Participants are asked to rate the severity of their symptoms over the previous 24 hours using a numerical rating scale of 0-10, with 0 meaning that the symptom is absent and 10 meaning the worst possible symptom. The mean is a composite outcome where change in the sum of 4 dehydration symptoms (fatigue, myoclonus, sedation and hallucinations) between day 4 and baseline ranged from 0-40 daily. The reported value was the mean of average change in patients' scores per group.

Participants rated delirium, quality of life, and overall survival using Richmond agitation sedition scale (RASS) where +4 is "Combative" to -5 is "Unarousable"; Memorial delirium assessment scale (MDAS), a ten-item, clinician-rated scale from 0 (none) to 3 (severe) for severity of delirium, for a total range of 0-30; and Unified Myoclonus Rating Scale (UMRS) 5-functional scores rated 0 to 4, for a total range of 0-20 where higher scores indicate more severe involuntary movements. Higher scores indicate worse outcomes for each scale, i.e. RASS more agitation, MDAS more delirium and UMRS more severe involuntary movements. The mean represents change in combined participant daily scores for each scale between Baseline and Day 4 assessments then separately Day 7 assessments. Reported value is mean of average change in patients' scores per group. Reported values reflect changes from baseline, either median decreases (less than 0), no change (0) or increases (greater than 0).

Change between Day 7 to Baseline in FACIT-F (Functional Assessment of Chronic illness Therapy-Fatigue) \& FACT-G (Functional Assessment of Cancer Therapy-General) scores. Participants rate quality of life using FACT-G consisting of 33 questions with 5 domains assessing physical and social, emotional \& functional well being \& relationship with physician, remaining 5 assess extent to which each domain affects overall quality of life on 5-point scale from 0 (not at all) to 4 (very much); total score obtained by summing individual subscale scores (0-132). FACIT-F consists of 13 items where participants rate intensity of fatigue \& its related symptoms on a scale of 0-4 from 0 "not at all" to 4 "very much." The responses to FACIT fatigue questionnaire are each measured on 4-point Likert scale with total score ranges from 0 to 52. High scores represent less fatigue. Reported is the mean change of the summed value of all reported scores for the FACT-G or the FACIT-F from baseline to Day 7.

Secondary outcomes included delirium, quality of life, and overall survival. The Nursing delirium screening scale (NuDESC) was used to assess delirium. NuDESC is a validated observational instrument conducted by research staff based on input from family caregivers. Five symptoms (disorientation, inappropriate behavior, inappropriate communication, illusions or hallucinations, and psychomotor retardation) are each given a score from 0 to 2, for a possible total score of 10. A higher NuDESC score indicates increased symptoms of delirium. It was observed a trend for lesser decline (delirium) in the hydration group, and significant worsening of night-time NuDESC scores in the placebo group.

Dehydration was assessed by using the Dehydration Assessment Scale on the basis of three physical findings, moisture on the mucous membranes of the mouth (0=moist, 1=somewhat dry, 2=dry), axillary moisture (0=moist, 1=dry) and sunkenness of the eyes (0=normal, 1=slight sunken, 2=sunken). These signs are selected due to their significant correlations with biological dehydration, as previously confirmed by elderly patients. The dehydration score (range 0-7) is calculated as the total of these 3 scores, a higher score indicates a higher level of dehydration. The reported value was the mean of average change in patients' scores per group.

National Institutes of Health (NIH)

National Cancer Institute (NCI)

M.D. Anderson Cancer Center

Placebo

Group 1: 1,000 ml of normal saline (0.9% sodium chloride) parenterally over 4 hours daily.

Hydration: Normal Saline (Salt Water)

Placebo: Lower Saline

Total

Age, Continuous

<=18 years

Between 18 and 65 years

>=65 years

Age, Customized

Sex: Female, Male

United States

Region of Enrollment

Study had a planned sample size of 150 participants but due to funding issues recruitment was halted after 129 patients; additionally, participants with delirium or severe dehydration were excluded for logistic purposes.

Dr. Eduardo Bruera, MD / Professor

Lower Amount of Normal Saline (salt water); 100 ml of normal saline (0.9% sodium chloride) parenterally over 4 hours daily.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Effect of Sodium Thiosulfate on Nephrotoxicity of Cisplatin Intraperitoneal Heat-perfusion Chemotherapy	NCT05877911	Epithelial Ovar... Acute Kidney In...	Sodium Sulfate Hydration Cisplatin	-	Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Effect of Sodium Thiosulfate on Nephrotoxicity of Cisplatin Intraperitoneal Heat-perfusion Chemotherapy	NCT05877911	Epithelial Ovar... Acute Kidney In...	Sodium Sulfate Hydration Cisplatin	-	Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Parenteral Hydration in Advanced Cancer Patients	NCT00423722	Advanced Cancer Dehydration	Saline Saline	18 Years -	M.D. Anderson Cancer Center
Parenteral Hydration in Advanced Cancer Patients	NCT00423722	Advanced Cancer Dehydration	Saline Saline	18 Years -	M.D. Anderson Cancer Center
Parenteral Hydration in Advanced Cancer Patients	NCT00423722	Advanced Cancer Dehydration	Saline Saline	18 Years -	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for hydration

Every month we try and update this database with for hydration cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for hydration

Every month we try and update this database with for hydration cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for hydration cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.